60 Oncology Research jobs in Hong Kong

Centre for Oncology and Immunology

• Contribute to collaborative research projects in discovery of cancer biomarkers using large-scale multi-omics approaches, organoid technology, and novel animal models, as well as anti-cancer or immuno-oncology drug development.

• Relevant research background and experience in Biomedical Sciences, Bioengineering and Biological Science, preferably in Cancer Biology, Immunology, Immuno-oncology, Molecular Biology, Genomics, Proteomics, Metabolomics, Bioinformatics, Single Cell Technology or Medicinal Chemistry.

• Possess a demonstrated track record of publishing academic research papers.
• Experience in molecular biology laboratory techniques, handling mammalian cell culture, animal handling techniques, mouse models and xenograft models.
• Understanding and/or experience in CRISPR/Cas9 technology, high-throughput screening techniques and single-cell sequencing technologies.

• Specialised research interests in immunology, oncology, molecular genetics, integrative genomics, T-cell based immunotherapies and immuno-oncology, T-cell non-Hodgkin lymphoma (L-NHL), multi-omics profiling, bioinformatics, cancer metabolism, tumour microenvironment or drug discovery.
• Some work experience in a medical research laboratory environment; experience at local universities or research core facilities is a plus.

Applicants should have a good command of written and spoken English, strong communication skills, and be self-motivated, hardworking and able to work well in an interdisciplinary team.

The appointees shall work in Hong Kong Science and Technology Park.

Overseas graduates are welcome to apply, and the awarding institution should be among the top 100 institutions for STEM-related subjects in QS/Shanghai Jiao Tong/Times Higher Education/U.S. News world university rankings.

Applicants for the Postdoctoral Fellow posts should possess a Ph.D. degree or an equivalent qualification in one of the relevant disciplines. (H03/2023/01/RP4)

Applicants for the Research Associate posts should have a master’s degree or an equivalent qualification in one of the relevant disciplines. (H03/2023/03/RP4)

Applicants for the Research Assistant posts should have a bachelor’s degree or an equivalent qualification in one of the relevant disciplines. (H03/2023/05/RP4)

A highly competitive salary commensurate with qualifications and experience will be offered, in addition to annual leave and medical benefits.

Submit your up-to-date CV and research publication list, quoting the job reference number, with information of current/expected remuneration and availability, to

Review of applications will commence as soon as possible or until the posts are filled, whichever is earlier.

The personal data provided in your application process will be used for recruitment and other employment-related purposes. The personal data may be transferred and disclosed to, and used by HKU Innovation Holdings Limited and The University of Hong Kong for the above purposes.

We are an equal opportunities employer and welcome applications from all qualified candidates.

4 days ago Be among the first 25 applicants

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Direct message the job poster from Fortrea

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

• Mid-Senior level

• Full-time

• Health Care Provider and Project Management

• Pharmaceutical Manufacturing

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 Associate

• Employment type Full-time

• Job function Research
• Industries Pharmaceutical Manufacturing

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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.

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 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 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.

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.

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

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

• Mid-Senior level

• Full-time

• Health Care Provider and Project Management

• Pharmaceutical Manufacturing

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 Associate

• Employment type Full-time

• Job function Research
• Industries Pharmaceutical Manufacturing

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