Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Covance 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 Covance 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 Covance 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.
•University/college 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).
•Full experience in PSV, SIV, RMV, COV in chemical drug, phase II/III.
•At least 1 year CRA experience for CRA I.
•At least 2 years CRA experience for CRA II.
•Oncology study experience is highly preferred.
•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.
•English workable is a MUST.