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Clinical Research Associate

2 months ago

Hong Kong, Central and Western District, Hong Kong SAR China HON Fortrea Hong Kong Limited Full time
Job Summary

HON Fortrea Hong Kong Limited is seeking a highly motivated and experienced Clinical Research Associate to join our Global Clinical Development team. As a Clinical Research Associate, you will be responsible for the delivery of clinical studies at allocated sites, working closely with local study teams and other CRAs to ensure timely and efficient study commitments.

Key Responsibilities
  • Contribute to the selection of potential investigators and ensure compliance with Procedural Documents, international guidelines, and local regulations.
  • Perform site qualification visits, collect and review documents, and submit applications to regulatory authorities as required.
  • Train, support, and advise investigators and site staff on study-related matters, including Risk-Based Quality Management principles.
  • Confirm that site staff have completed required trainings, including ICH-GCP training, and ensure sites are inspection-ready at all times.
  • Participate in Local Study Team meetings and contribute to National Investigators meetings as applicable.
  • Initiate, monitor, and close study sites in compliance with Procedural Documents and share information on patient recruitment and study site progress within the LST.
  • Drive performance at sites, proactively identify and resolve study-related issues, and escalate them as necessary.
  • Update CTMS and other systems with data from study sites as per required timelines.
  • Manage study supplies, drug supplies, and drug accountability at study sites, and prepare study drug for destruction as applicable.
  • Perform monitoring visits, remote data checks, and Source Data Verification in accordance with the Monitoring Plan.
  • Ensure data query resolution in a timely manner and work with data management to ensure robust quality of collected study data.
  • Report Serious Adverse Events and their follow-ups accurately and in a timely manner.
  • Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to the Principal Investigator.
  • Follow up on outstanding actions with study sites to ensure resolution in a timely manner.
  • Escalate systematic or serious quality issues, data privacy breaches, or compliance issues to Local Management and/or CQM as required.
  • Assist sites in maintaining inspection-ready ISF and prepare for and collaborate with activities associated with audits and regulatory inspections.
  • Ensure timely collection and uploading of essential documents into the eTMF in accordance with ICH-GCP, SOPs, and local requirements.
  • Ensure all study documents under their responsibility are available and ready for final archiving and completion of the local part of the eTMF.
  • Provide feedback on research-related information, including sites, investigators, and competing studies that may be useful for the local market.
  • Ensure compliance with Code of Ethics, company policies, and procedures relating to people, finance, technology, security, and SHE.
  • Ensure compliance with local, national, and regional legislation as applicable.
  • Collaborate with local MSLs as directed by LSM or line manager.
Requirements

To be successful in this role, you will need to have a strong background in clinical research, excellent communication and interpersonal skills, and the ability to work independently and as part of a team. You will also need to be proficient in using CTMS and other relevant systems.

What We Offer

HON Fortrea Hong Kong Limited offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a collaborative and inclusive work environment that supports the well-being and success of our employees.