Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Standard Operating Procedures, ICH Guidelines and GCP, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
Responsibilities and duties include, but are not limited to the following: - Take charge of all aspects of Site Management as prescribed in the project plans. - Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study-related documentation, and organize meetings and other tasks as instructed by supervisor. - Negotiate study budgets with potential investigators and collaborate with the legal department with statements of agreements as assigned. - Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. - Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management. - Assist with training, mentoring, and development of new employees, e.g. co-monitoring. - Perform other duties as assigned by management.
Education/Qualifications: - Bachelor degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). - Workable English in reading & writing. Basic oral English ability.
Experience: - In lieu of the above requirement, candidates with at least 1 or more years of CRA experience in pharmaceutical or CRO industries will be considered. - Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines. - Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
Preferred: - 2 or more additional years of experience as CRA. More years of experience preferred if apply senior level CRA positions. - Oncology study experience preferred. - Global study experience preferred.
