7 Pharmaceutical Development jobs in Hong Kong

Clinical Research Associate

Tigermed

Posted 10 days ago

Job Viewed

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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

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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

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Clinical Research Associate

Hong Kong, Hong Kong Tigermed

Posted today

Job Viewed

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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

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Clinical Research Associate (MJ000011)

Tigermed

Posted 10 days ago

Job Viewed

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Job Description

3 days ago Be among the first 25 applicants

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

Sign in to set job alerts for “Clinical Research Associate” roles. Temporary / Part-time Research Assistant I (N&HS) Temporary / Part-time Research Assistant I (N&HS) - (25001MB)

Islands District, Hong Kong SAR 2 weeks ago

Research Assistant II (R7045) (N&HS) - (25001L1) Research Assistant (Fresh Graduates Welcome) Clinical Research Associate II, Hong Kong Clinical Trials Assistant (CTA) (Evergreen)

Kwai Tsing District, Hong Kong SAR 2 weeks ago

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Clinical Research Associate (MJ000011)

Hong Kong, Hong Kong Tigermed

Posted 3 days ago

Job Viewed

Tap Again To Close

Job Description

3 days ago Be among the first 25 applicants

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

Sign in to set job alerts for “Clinical Research Associate” roles. Temporary / Part-time Research Assistant I (N&HS) Temporary / Part-time Research Assistant I (N&HS) - (25001MB)

Islands District, Hong Kong SAR 2 weeks ago

Research Assistant II (R7045) (N&HS) - (25001L1) Research Assistant (Fresh Graduates Welcome) Clinical Research Associate II, Hong Kong Clinical Trials Assistant (CTA) (Evergreen)

Kwai Tsing District, Hong Kong SAR 2 weeks ago

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Clinical Research Associate (Hong Kong)

Fortrea

Posted 10 days ago

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Job Description

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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)

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
  • 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 and in English, both written and verbal.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required)

  • External Candidates:
  • 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.
  • Internal Candidates:
  • Internal candidates with a minimum of 2 years of Clinical Monitoring experience.
  • Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
  • Ability to work with minimal supervision.
  • Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
  • Good planning, organization, and problem-solving abilities.
  • Works efficiently and effectively in a matrix environment.

Preferred Qualifications Include

  • Thorough working knowledge of Fortrea SOPs for site monitoring.
  • One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
  • Phase I monitoring experience.
  • Life Science or Nursing qualification.
  • Specific skills, systems, certifications, and/or licenses preferred.
  • Personal characteristics (leadership, problem solving, interpersonal skills).
  • Good attention to detail.
  • Methodical approach to work.
  • Good understanding of medical and clinical research terminology and clinical research processes.
  • An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).
  • Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements.
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
  • Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.
  • Focus on Customer.
  • Innovate and Change.
  • Pursue Scientific and Process Excellence.
  • Work with Others.
  • Achieve Results.
  • Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
  • Demonstrated ability to conduct clinical operations activities most effectively and efficiently.
  • Good analytical and negotiation skills.
  • Experience using e-clinical systems (e.g., clinical trial management system (CTMS)).
  • For medical device positions, experience in providing customer service to device end users.

Physical Demands/Work Environment

  • Must be able to sit at a computer for long periods of time.
  • Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.
  • Standard office and/or home working environment.
  • Clinical Research Unit and hospital environment (administrative only).
  • Risk of eye strain.
  • Will involve outside of normal office hours as required by the role.
  • Travel Requirement is 60% of the time (traveling to study sites).

Learn more about our EEO & Accommodations request here.

Seniority level
  • Seniority level Entry level
Employment type
  • Employment type Full-time
Job function
  • Job function Research, Analyst, and Information Technology

Referrals increase your chances of interviewing at Fortrea by 2x

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

Clinical Trials Assistant (CTA) (Evergreen)

Kwai Tsing District, Hong Kong SAR 1 week ago

Research Assistant I/II (Ref.: H01/2025/067) Research Assistant (Fresh Graduates Welcome) Part-time Research Assistant (Project No: R6542) (E&L) Part-time Research Assistant (Project No: R6542) (E&L) - (250019L) Part-time Research Assistant (Project No: R4113) (E&L) (Senior) Clinical Research Associate (CRA)

Kwai Tsing District, Hong Kong SAR 1 week ago

Part-time Research Assistant (Project No: R4113) (E&L) - (250016I) Temporary Research Assistant II (N&HS) - (25001CC)

Kwai Tsing District, Hong Kong SAR 1 week ago

Clinical Research Associate II (Hong Kong) Temporary Research Assistant I (Project Code: RD/2023/2.6) (A&SS) Clinical Research Associate II(FSP, Client office-base) Research Assistant II (R6660) (S&T) - (25001E0) Part-time Research Assistant II (ELR2501) (E&L) Research Assistant I/II (Cancer Immunology) Postdoctoral Fellow / Research Associate / Research Assistant

New Territories, Hong Kong SAR 9 hours ago

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(Senior) Clinical Research Associate (CRA)

IQVIA

Posted 10 days ago

Job Viewed

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Job Description

Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least 1 year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Clinical Research Associate (Hong Kong)

Hong Kong, Hong Kong Fortrea

Posted 2 days ago

Job Viewed

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Job Description

Join to apply for the Clinical Research Associate (Hong Kong) role at Fortrea

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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)
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
  • 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 and in English, both written and verbal.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required)
  • External Candidates:
  • 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.
  • Internal Candidates:
  • Internal candidates with a minimum of 2 years of Clinical Monitoring experience.
  • Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
  • Ability to work with minimal supervision.
  • Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
  • Good planning, organization, and problem-solving abilities.
  • Works efficiently and effectively in a matrix environment.
Preferred Qualifications Include
  • Thorough working knowledge of Fortrea SOPs for site monitoring.
  • One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
  • Phase I monitoring experience.
  • Life Science or Nursing qualification.
  • Specific skills, systems, certifications, and/or licenses preferred.
  • Personal characteristics (leadership, problem solving, interpersonal skills).
  • Good attention to detail.
  • Methodical approach to work.
  • Good understanding of medical and clinical research terminology and clinical research processes.
  • An understanding of the basics of physiology, pharmacology, and medical devices (when applicable).
  • Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements.
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
  • Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English.
  • Focus on Customer.
  • Innovate and Change.
  • Pursue Scientific and Process Excellence.
  • Work with Others.
  • Achieve Results.
  • Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors.
  • Demonstrated ability to conduct clinical operations activities most effectively and efficiently.
  • Good analytical and negotiation skills.
  • Experience using e-clinical systems (e.g., clinical trial management system (CTMS)).
  • For medical device positions, experience in providing customer service to device end users.
Physical Demands/Work Environment
  • Must be able to sit at a computer for long periods of time.
  • Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day.
  • Standard office and/or home working environment.
  • Clinical Research Unit and hospital environment (administrative only).
  • Risk of eye strain.
  • Will involve outside of normal office hours as required by the role.
  • Travel Requirement is 60% of the time (traveling to study sites).
Learn more about our EEO & Accommodations request here. Seniority level
  • Seniority level Entry level
Employment type
  • Employment type Full-time
Job function
  • Job function Research, Analyst, and Information Technology

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