Responsibilities/Duties:
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.


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).


Experience:
In lieu of the above requirement, candidates with three or more years of relevant clinical research 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:
One or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. More years of experience preferred if apply senior level CRA positions.