16 Icon Plc jobs in Hong Kong

Clinical Research Associate

Fortrea

Posted today

Job Viewed

Tap Again To Close

Job Description

4 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from Fortrea

Talent Acquisition Partner @ Fortrea | HR Certification, Master's Degree

This role is for upcoming future opportunities that may arise at Fortrea.

Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer.

Summary of Responsibilities:

  • Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
  • Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
  • Prepares and implements project plans related to Clinical Monitoring responsibilities.
  • Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
  • Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
  • Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
  • Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
  • Ensures adherence to global quality control and CRA performance metrics.
  • Ensures audit readiness at site level.
  • Acts in the project role of a Lead CRA as assigned.
  • General On-Site Monitoring Responsibilities:
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
  • Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
  • Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
  • Travel, including air travel, may be required and is an essential function of the job.
  • Prepare and submit accurate and timely trip reports.
  • Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
  • Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
  • Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
  • Track IP shipments and supplies, as needed.
  • Track and follow-up on serious adverse events as assigned.
  • Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
  • Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
  • Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed.
  • Present training content for site initiation.
  • Assist with training of new employees (e.g., co-monitoring).
  • All other duties as needed or assigned.

Qualifications (Minimum Required):

  • B.A./B.S. (Life Science preferred) or equivalent healthcare experience.
  • Minimum 1 year experience as CRA. Has conducted on site monitoring in Hong Kong in the past 3 months.
  • In lieu of the above requirement, CRA II: candidates with 2 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered.
  • SCRA: candidates with 3 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered.
  • Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
  • Basic understanding of the clinical trial process.
  • Fluent in local language and English.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Health Care Provider and Project Management
Industries
  • Pharmaceutical Manufacturing

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate

Tigermed

Posted 22 days ago

Job Viewed

Tap Again To Close

Job Description

Direct message the job poster from Tigermed

1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management

•Study site selection, initiation (SIV) and clinical monitoring.

•Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

•Track study recruitment to ensure recruitment target is achieved in all studies.

•Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

•Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

•Assemble site specific EC submission dossier, and ensure submission to EC.

Training

•Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

•Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

•Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

•Prepare/complete study records’ archiving according to protocol and sponsor requirements.

(b) Drug Safety

•Ensure safety information is disseminated to all sites according SOP and applicable regulations.

•Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

•Finalize budget and obtain signed contract from site, prior to site initiation visit.

•Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

•Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 1 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Seniority level
  • Seniority level Associate
Employment type
  • Employment type Full-time
Job function
  • Job function Research
  • Industries Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Tigermed by 2x

Get notified about new Clinical Research Associate jobs in Hong Kong, Hong Kong SAR .

Research Assistant (Fresh Graduates Welcome)

Islands District, Hong Kong SAR 11 hours ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate

$60000 - $120000 Y Fortrea

Posted today

Job Viewed

Tap Again To Close

Job Description

This role is for upcoming future opportunities that may arise at Fortrea.

Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer.

Summary of Responsibilities:

  • Site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
  • Conducts site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
  • Prepares and implements project plans related to Clinical Monitoring responsibilities.
  • Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
  • Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
  • Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
  • Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
  • Ensures adherence to global quality control and CRA performance metrics.
  • Ensures audit readiness at site level.
  • Acts in the project role of a Lead CRA as assigned.
  • General On-Site Monitoring Responsibilities:
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
  • Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
  • Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
  • Travel, including air travel, may be required and is an essential function of the job.
  • Prepare and submit accurate and timely trip reports.
  • Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
  • Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
  • Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
  • Track IP shipments and supplies, as needed.
  • Track and follow-up on serious adverse events as assigned.
  • Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
  • Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
  • Attend investigators' meetings (if applicable), project team meetings and teleconferences, and others as needed.
  • Present training content for site initiation.
  • Assist with training of new employees (e.g., co-monitoring).
  • All other duties as needed or assigned.

Qualifications (Minimum Required):


•B.A./B.S. (Life Science preferred) or equivalent healthcare experience.


•Minimum 2 years experience as CRA. Has conducted on site monitoring in Hong Kong in the past 3 months.


•In lieu of the above requirement,

-CRA II: candidates with 2 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered.

-SCRA: candidates with 3 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered.


•Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements.


•Basic understanding of the clinical trial process.


•Fluent in local language and English.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit

This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate

$600000 - $1200000 Y Fortrea

Posted today

Job Viewed

Tap Again To Close

Job Description

This role is for upcoming future opportunities that may arise at Fortrea.

Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer.

Summary of Responsibilities:

  • Site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
  • Conducts site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
  • Prepares and implements project plans related to Clinical Monitoring responsibilities.
  • Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
  • Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
  • Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
  • Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
  • Ensures adherence to global quality control and CRA performance metrics.
  • Ensures audit readiness at site level.
  • Acts in the project role of a Lead CRA as assigned.
  • General On-Site Monitoring Responsibilities:
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
  • Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
  • Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
  • Travel, including air travel, may be required and is an essential function of the job.
  • Prepare and submit accurate and timely trip reports.
  • Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
  • Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
  • Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
  • Track IP shipments and supplies, as needed.
  • Track and follow-up on serious adverse events as assigned.
  • Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
  • Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
  • Attend investigators' meetings (if applicable), project team meetings and teleconferences, and others as needed.
  • Present training content for site initiation.
  • Assist with training of new employees (e.g., co-monitoring).
  • All other duties as needed or assigned.

Qualifications (Minimum Required):


•B.A./B.S. (Life Science preferred) or equivalent healthcare experience.


•Minimum 1 year experience as CRA. Has conducted on site monitoring in Hong Kong in the past 3 months.


•In lieu of the above requirement,

-CRA II: candidates with 2 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered.

-SCRA: candidates with 3 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered.


•Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements.


•Basic understanding of the clinical trial process.


•Fluent in local language and English.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit

This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate

$600000 - $800000 Y Fortrea Hong Kong Limited

Posted today

Job Viewed

Tap Again To Close

Job Description

This role is for upcoming future opportunities that may arise at Fortrea.

Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer.

Summary of Responsibilities:

  • Site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
  • Conducts site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
  • Prepares and implements project plans related to Clinical Monitoring responsibilities.
  • Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
  • Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
  • Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
  • Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
  • Ensures adherence to global quality control and CRA performance metrics.
  • Ensures audit readiness at site level.
  • Acts in the project role of a Lead CRA as assigned.
  • General On-Site Monitoring Responsibilities:
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
  • Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
  • Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
  • Travel, including air travel, may be required and is an essential function of the job.
  • Prepare and submit accurate and timely trip reports.
  • Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
  • Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
  • Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
  • Track IP shipments and supplies, as needed.
  • Track and follow-up on serious adverse events as assigned.
  • Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
  • Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
  • Attend investigators' meetings (if applicable), project team meetings and teleconferences, and others as needed.
  • Present training content for site initiation.
  • Assist with training of new employees (e.g., co-monitoring).
  • All other duties as needed or assigned.

Experience & Qualifications (Minimum Required):

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND
  • A minimum of 2 years of Clinical Monitoring experience.
  • Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
  • Thorough knowledge of monitoring procedures.
  • Basic understanding of the clinical trial process.
  • Fluent in local office language(Cantonese) and in English, both written and verbal.

  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate

$40000 - $80000 Y The University of Hong Kong

Posted today

Job Viewed

Tap Again To Close

Job Description

Clinical Research Associate (at the rank of Technical Officer/Research Assistant I/II) in the Clinical Trials Centre (Ref:

The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under The University of Hong Kong LKS Faculty of Medicine (HKUMed) and is dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices and medical technologies.  HKU-CTC offers long-term development opportunities to passionate talents who are devoted to a career in the clinical trial profession.

Clinical studies are highly sophisticated, multi-disciplinary projects that require good planning, close monitoring and synchronization of research team members and activities.  HKU-CTC's Project Operations Unit (POU) is a professional unit dedicated to facilitating clinical study planning, performance and completion in compliance with international standards and in an efficient and high-quality manner.  POU is seeking talents who are interested/experienced in practising the project management profession in clinical research.  Comprehensive on-job training will be provided.  Fresh graduates will also be considered.

Main Responsibilities:

  • Act as a key contact person among clinical study centres, sponsoring companies, regulatory authorities and other stakeholders to coordinate clinical trial activities;
  • Facilitate the planning, initiation and monitoring of clinical studies throughout their project life cycles, ensuring adherence to protocols and regulatory requirements;
  • Assess the feasibility of clinical studies at potential sites to support study planning;
  • Conduct various visits (including Pre-Study Visits (PSV), Site Initiation Visits (SIV), Site Closure Visits (COV) and Monitoring Visits (MV)) to verify compliance, data integrity, and participant safety;
  • Support study planning, preparation and initiation (e.g. setting study time plans/milestones, assisting in obtaining ethics and regulatory approvals, importing study products, coordinating logistics and workflows, and organizing study setup);
  • Review and verify study data and source documentation for accuracy and completeness;
  • Monitor the progress and quality of study activities (both on-site at study centres and remotely via electronic data capture systems);
  • Oversee study centres' compliance with study protocols, Good Clinical Practice (GCP) and other research ethics and regulatory requirements, prepare and write monitoring reports;
  • Assist in the proper closure of clinical studies;
  • Facilitate study audits and inspections as needed; and
  • Perform other duties related to clinical trial management as assigned.

Requirements:

  • Bachelor's degree or above in Health, Biological/Life Sciences, Medical, Pharmacy, Nursing or related disciplines;
  • Experience in clinical research operations and development, and/or basic knowledge in Good Clinical Practice (GCP) are added advantages;
  • Good interpersonal and communication skills allowing collaboration with cross-functional teams;
  • Good coordination and problem-solving skills, and commitment to quality and compliance;
  • Detail-minded, able to handle multiple concurrent tasks, and have a strong sense of responsibility; and
  • Good command of written and spoken English and Cantonese (proficiency in Putonghua is a plus).

The appointment will commence as soon as possible on a 1-year temporary basis or 2-year fixed-term basis, with the possibility of renewal subject to satisfactory performance.  A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits.  Appointment on 2-year fixed term basis will attract a contract-end gratuity and University contribution to a retirement benefits scheme, totalling up to 10% of basic salary.

Application Procedure

The University only accepts online application for the above post.  Applicants should apply online at the University's careers site ) and upload an up-to-date C.V.  Review of applications will start from October 9, 2025 and continue until October 25, 2025, or until the post is filled, whichever is earlier.

This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate

Hong Kong, Hong Kong Fortrea

Posted today

Job Viewed

Tap Again To Close

Job Description

4 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from Fortrea

Talent Acquisition Partner @ Fortrea | HR Certification, Master's Degree

This role is for upcoming future opportunities that may arise at Fortrea.

Fortrea is excited to connect with talented individuals for future opportunities. If you meet the job requirements, we'll invite you for an interview. If you're pre-selected, our recruiter will keep in touch and let you know when the role officially opens, so we can reconfirm your interest before moving forward with an offer.

Summary of Responsibilities:

  • Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
  • Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
  • Prepares and implements project plans related to Clinical Monitoring responsibilities.
  • Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
  • Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
  • Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
  • Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.
  • Ensures adherence to global quality control and CRA performance metrics.
  • Ensures audit readiness at site level.
  • Acts in the project role of a Lead CRA as assigned.
  • General On-Site Monitoring Responsibilities:
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data.
  • Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required.
  • Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
  • Travel, including air travel, may be required and is an essential function of the job.
  • Prepare and submit accurate and timely trip reports.
  • Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
  • Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management.
  • Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems.
  • Track IP shipments and supplies, as needed.
  • Track and follow-up on serious adverse events as assigned.
  • Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met.
  • Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned.
  • Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed.
  • Present training content for site initiation.
  • Assist with training of new employees (e.g., co-monitoring).
  • All other duties as needed or assigned.

Qualifications (Minimum Required):

  • B.A./B.S. (Life Science preferred) or equivalent healthcare experience.
  • Minimum 1 year experience as CRA. Has conducted on site monitoring in Hong Kong in the past 3 months.
  • In lieu of the above requirement, CRA II: candidates with 2 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered.
  • SCRA: candidates with 3 more years of CRA monitoring experience in pharmaceutical or CRO industries may be considered.
  • Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
  • Basic understanding of the clinical trial process.
  • Fluent in local language and English.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Health Care Provider and Project Management
Industries
  • Pharmaceutical Manufacturing
#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.
Be The First To Know

About the latest Icon plc Jobs in Hong Kong !

Clinical Research Associate

Hong Kong, Hong Kong Tigermed

Posted 3 days ago

Job Viewed

Tap Again To Close

Job Description

Direct message the job poster from Tigermed

1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management

•Study site selection, initiation (SIV) and clinical monitoring.

•Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

•Track study recruitment to ensure recruitment target is achieved in all studies.

•Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

•Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

•Assemble site specific EC submission dossier, and ensure submission to EC.

Training

•Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

•Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

•Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

•Prepare/complete study records’ archiving according to protocol and sponsor requirements.

(b) Drug Safety

•Ensure safety information is disseminated to all sites according SOP and applicable regulations.

•Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

•Finalize budget and obtain signed contract from site, prior to site initiation visit.

•Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

•Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 1 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Seniority level
  • Seniority level Associate
Employment type
  • Employment type Full-time
Job function
  • Job function Research
  • Industries Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Tigermed by 2x

Get notified about new Clinical Research Associate jobs in Hong Kong, Hong Kong SAR .

Research Assistant (Fresh Graduates Welcome)

Islands District, Hong Kong SAR 11 hours ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate II/ Senior Clinical Research Associate

$600000 - $1200000 Y ICON Strategic Solutions

Posted today

Job Viewed

Tap Again To Close

Job Description

CRA II/ Senior CRA - office-based in Hong Kong. Join us and advance your career with an industry leading CRO.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.

What You Will Be Doing

  • Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
  • Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
  • Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
  • Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
  • Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

  • Advanced degree in a relevant field such as life sciences, nursing, or medicine.
  • Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
  • Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
  • Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
  • Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
  • Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license

What ICON Can Offer You
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

This advertiser has chosen not to accept applicants from your region.

Clinical Research Associate II/ Senior Clinical Research Associate

Hong Kong, Hong Kong ICON Clinical Research

Posted 11 days ago

Job Viewed

Tap Again To Close

Job Description

CRA II/ Senior CRA - office-based in Hong Kong. Join us and advance your career with an industry leading CRO.
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
**What You Will Be Doing:**
+ Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
+ Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
+ Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
+ Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
+ Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
**Your Profile:**
+ Advanced degree in a relevant field such as life sciences, nursing, or medicine.
+ Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
+ Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
+ Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
+ Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
This advertiser has chosen not to accept applicants from your region.
 

Nearby Locations

Other Jobs Near Me

Industry

  1. request_quote Accounting
  2. work Administrative
  3. eco Agriculture Forestry
  4. smart_toy AI & Emerging Technologies
  5. school Apprenticeships & Trainee
  6. apartment Architecture
  7. palette Arts & Entertainment
  8. directions_car Automotive
  9. flight_takeoff Aviation
  10. account_balance Banking & Finance
  11. local_florist Beauty & Wellness
  12. restaurant Catering
  13. volunteer_activism Charity & Voluntary
  14. science Chemical Engineering
  15. child_friendly Childcare
  16. foundation Civil Engineering
  17. clean_hands Cleaning & Sanitation
  18. diversity_3 Community & Social Care
  19. construction Construction
  20. brush Creative & Digital
  21. currency_bitcoin Crypto & Blockchain
  22. support_agent Customer Service & Helpdesk
  23. medical_services Dental
  24. medical_services Driving & Transport
  25. medical_services E Commerce & Social Media
  26. school Education & Teaching
  27. electrical_services Electrical Engineering
  28. bolt Energy
  29. local_mall Fmcg
  30. gavel Government & Non Profit
  31. emoji_events Graduate
  32. health_and_safety Healthcare
  33. beach_access Hospitality & Tourism
  34. groups Human Resources
  35. precision_manufacturing Industrial Engineering
  36. security Information Security
  37. handyman Installation & Maintenance
  38. policy Insurance
  39. code IT & Software
  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
View All Icon Plc Jobs