Clinical Research Associate

1 month ago

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

Company Overview


Hon Fortrea Hong Kong Limited is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience.


We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.


Job Summary


The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s).


The CRA works in close collaboration with other CRAs and the Local Study Team/Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner.


Key Responsibilities



  • Contributes to the selection of potential investigators.
  • In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance.
  • Trains, supports, and advises Investigators and site staff in study-related matters, including Risk-Based Quality Management (RbQM) principles.
  • Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study.
  • Ensures the sites are inspection ready at all times.
  • Actively participates in Local Study Team (LST) meetings.
  • Contributes to National Investigators meetings, as applicable.
  • Initiates, monitors, and closes study sites in compliance with Procedural Documents.
  • Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
  • Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
  • Updates CTMS and other systems with data from study sites as per required timelines.
  • Manages study supplies (ISF, etc), drug supplies, and drug accountability at study site. Prepares study drug for destruction, if applicable.
  • Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study-specific Monitoring Plan.
  • Performs Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV), in accordance with the Monitoring Plan.
  • Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
  • Ensures data query resolution in a timely manner.
  • Works with data management to ensure robust quality of the collected study data.
  • Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups.
  • Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with SOP.
  • Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
  • Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.
  • Assists site in maintaining inspection-ready ISF.
  • Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSM and CQM.
  • Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, SOPs, and local requirements.
  • Supports/participates in regular QC checks performed by LSM or delegate.
  • Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
  • Provides feedback on any research-related information, including sites/investigators/competing studies, that might be useful for the local market.
  • Ensures compliance with Code of Ethics, company policies, and procedures relating to people, finance, technology, security, and SHE (Safety, Health, and Environment).
  • Ensures compliance with local, national, and regional legislation, as applicable.
  • Collaborates with local MSLs as directed by LSM or line manager.

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