159 Healthcare Research jobs in Hong Kong
Healthcare Research Analyst
Posted today
Job Viewed
Job Description
Responsibilities
- Assist leading sector analyst in performing in-depth research on public healthcare companies
- Monitoring industry trends, staying updated on clinical trials and regulatory changes Conducting valuations, and communicating insights through presentations and written reports
- Participate in IPO projects under compliance framework
- Other duties assigned by supervisor
Requirements
- Master's degree or above in Biotech, Finance or any related fields from prestigious Universities
- Minimum of 2 years of experience in either sell-side or buy-side healthcare research
- Strong analytical skills, financial modeling expertise, and excellent communication abilities to translate complex data into actionable investment advice.
- Excellent written and verbal communication skills in both English and Chinese
- Ability to work effectively in a fast-paced, dynamic environment and manage multiple projects simultaneously
We offer competitive remuneration packages to the successful candidates. Interested candidates may send your detailed resume with current & expected salary and availability.
All information collected will be kept in strict confidence and will be used for recruitment purpose only.
Healthcare Equity Research Analyst G00476
Posted today
Job Viewed
Job Description
Equity Research Analyst – Healthcare Sector (Hong Kong)
Position Overview:
Our client, a leading Chinese securities firm in Hong Kong, is seeking an Equity Research Analyst to cover the Healthcare sector, with a focus on Hong Kong-listed pharmaceutical companies. The ideal candidate will possess a hybrid background combining expertise in life sciences/medicine with strong financial analysis skills.
Key Responsibilities :
- Independently conduct in-depth research and analysis on Hong Kong-listed pharmaceutical enterprises, covering sub-sectors such as biotech, innovative pharmaceuticals, and healthcare services.
- Develop and maintain detailed financial models to evaluate company valuations, growth drivers, and risk exposures (e.g., regulatory approvals, patent cliffs).
- Produce high-quality, actionable research reports including thematic studies, company-specific updates, and sector reviews covering regulatory shifts, clinical trials, and product launches.
- Monitor and interpret global pharmaceutical industry trends (e.g., novel therapies, M&A, FDA/EMA regulations) and assess their impact on Hong Kong-listed equities.
- Engage with internal teams (especially mainland China-based pharmaceutical analysts) to align research views, share insights on cross-border trends, and ensure cohesive cross-market analysis.
- Communicate investment recommendations effectively through written reports, client meetings, and formal presentations tailored to both financial and non-financial audiences.
- Attend industry conferences, conduct company site visits, and network with key opinion leaders (e.g., clinicians, consultants) to enhance sector expertise.
Requirements
- Master's or higher in Life Sciences (Biochemistry, Microbiology, etc.), Medicine, Pharmacy, Finance, or Economics. Advanced degrees (PhD, MBA) or professional certifications (CFA, FRM) are strongly preferred.
- Minimum 2 years of sell-side equity research experience focusing on the healthcare/pharmaceutical sector; familiarity with Hong Kong markets and HKEX regulations is a significant advantage.
- Demonstrated ability to independently manage sector coverage, generate investment ideas, and support decision-making through rigorous analysis.
- Proficiency in translating complex scientific/medical data (e.g., clinical trial results) into investable insights.
- Strong financial modeling skills and familiarity with data analysis tools.
- Fluency in English and Mandarin (written and spoken); exceptional communication and presentation skills.
Ideal Profile
The successful candidate will be a proactive, detail-oriented analyst with a passion for the healthcare sector and the ability to work both independently and collaboratively within a cross-border team. Prior exposure to Hong Kong or Greater China equity markets is highly valued.
Research Scientist/ Associate Scientist
Posted today
Job Viewed
Job Description
Position (full-time): Research Scientist/ Associate Scientist (Molecular Biology)
Responsibilities
- Execute molecular biology experiments according to established protocols, including PCR, qPCR, gel electrophoresis and plasmid extraction
- Perform mammalian cell culture experiments such as transfection, fluorescence microcopy, FACS and other cell-based assays in a BSL-2 laboratory setting
- Provide technical support for performing quality control experiments
- Visualise and present experimental results to supervisor
- Account for agreed experiment timelines
- Contribute to the development of safer and more efficient delivery of therapeutic gene-editing agents
- Candidate with more experience will be considered as Research Assistant
Requirements
- A Master's degree (or Bachelor's degree with at least one-year relevant lab experience) in life sciences, biomedical sciences, biochemistry, microbiology or related discipline
- Hands-on experience in PCR-based assays, mammalian cell culture and FACS
- Willingness to ask scientific questions, provide solutions to technical problems and learn new research methods
Preferred Requirements
- Experience in CRISPR (or other gene editors)
- Understanding and hands-on experience in working with nanoparticles and specimens of animal and human origins
- Experience in using R, ggplot2 and GraphPad Prism in statistical analysis and data visualisation.
- Adaptable to a fast-paced working environment
Research Associate, Research
Posted today
Job Viewed
Job Description
CITIC CLSA provides global investors and corporate executives with insights, liquidity and capital to drive their growth strategies.
Award-winning research, an extensive Asia footprint, direct links to China and highly experienced finance professionals differentiate our innovative products and services in asset management, corporate finance, equity and debt capital markets, securities and wealth management.
As part of CITIC Securities (SSE: , SEHK: 6030), China's leading investment bank, CITIC CLSA is uniquely positioned to facilitate cross-border capital flows and connect China to the world and the world to China.
CITIC CLSA operates from 13 countries across Asia, Australia, Europe and the Americas. For further information, please visit
Position Description
This role is to support the Lead Analyst based in Hong Kong. He/She will be responsible for supporting China consumer and education sector and stock coverage. Utilizing industry knowledge in technologies and financial analysis/valuation skills, he/she will derive investment recommendation on sub-sector and single stock, by communicating with impact in both written and verbal form to global institutional investors.
Key Areas of Responsibilities
- Support sector research analysts for preparation of market reports and presentation materials
- Retrieve and analyse information from databases, external data (e.g. Bloomberg, Factset, CEIC, WIND, etc), industry sources and companies for the stocks under coverage within a given sector, maintain and update industry database models.
- Help track and analyse news relating to the sector
- Responsible for client requests
- Following company result announcements, this person will be responsible for updating models/ records for specific companiesTravel to China for company visits and conduct independent company analysis
- Analyse market dynamics (e.g. valuations, liquidity, fund flows) and perform stock screenings
Requirements
- Bachelor degree or above, preferably in business related or quantitative discipline
- Minimum 2 to 3 years of relevant experience in secondary market stock analysis will be preferred. Experience in big four accountancy firms will also be considered
- Attitude is the key - hardworking and responsible
- Excellent problem solving and analytical skills
- Understanding of financial modelling and strong Excel skills
- High sense of commercial awareness
- Quick learner and able to work under pressure
- Excellent interpersonal sensitivity. Excellent communication and management skills to both internal and external clients
- Fluent in English and Mandarin is a must
Research Associate, Research
Posted today
Job Viewed
Job Description
CITIC CLSA provides global investors and corporate executives with insights, liquidity and capital to drive their growth strategies.
Award-winning research, an extensive Asia footprint, direct links to China and highly experienced finance professionals differentiate our innovative products and services in asset management, corporate finance, equity and debt capital markets, securities and wealth management.
As part of CITIC Securities (SSE: , SEHK: 6030), China's leading investment bank, CITIC CLSA is uniquely positioned to facilitate cross-border capital flows and connect China to the world and the world to China.
CITIC CLSA operates from 13 countries across Asia, Australia, Europe and the Americas. For further information, please visit
Position Description
This position is responsible for providing support to Research Analyst covering the renewable space. The role is primarily responsible for assisting with the building and servicing of financial models, the analysis of data and the production of the research product. The individual will also assist in compiling news and working with the analyst to provide commentary on the impact on the respective stocks and sectors.
Key Areas of Responsibilities
- Support sector research analysts for preparation of market reports and presentation materials, including solar, energy storage and other renewables.
- Retrieve and analyse information from databases, external data (e.g. Bloomberg, CEIC, WIND, etc), industry sources and companies for the stocks under primary coverage within a given sector.
- Help track and analyse news relating to the sector
- Helps sector research analysts with client requests
- Follow company result announcements, this person will be responsible for updating models/ records for specific companies that he/she might cover individually.
- Travel to China to for company visits and conduct independent company analysis
Requirements
- Bachelor degree required, but Master's degree preferred, preferably in business related or quantitative discipline
- 2-3 years' work experience preferred, but not required
- Experience in a large accountancy firm will also be considered
- Excellent problem solving and analytical skills
- Understanding of financial modelling and strong Excel skills
- High sense of commercial awareness
- Excellent interpersonal sensitivity. Excellent communication and management skills to both internal and external clients
- Fluent in English is a must and fluent Mandarin preferred
Clinical Research Associate
Posted today
Job Viewed
Job Description
4 days ago Be among the first 25 applicants
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Direct message the job poster from Fortrea
Talent Acquisition Partner @ Fortrea | HR Certification, Master's DegreeThis 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
- Full-time
- Health Care Provider and Project Management
- Pharmaceutical Manufacturing
Clinical Research Associate
Posted 22 days ago
Job Viewed
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 Full-time
- Job function Research
- Industries Pharmaceutical Manufacturing
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Clinical Research Associate
Posted today
Job Viewed
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
Clinical Research Associate
Posted today
Job Viewed
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
Clinical Research Associate
Posted today
Job Viewed
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.