Clinical Study Assistant
At ProClinical, we are seeking a dynamic and engaged individual to fill the role of Clinical Study Assistant, based in Santa Ana, CA. The successful candidate will provide administrative and organizational support for assigned clinical trials and sites, and will collaborate closely with other members within Clinical R&D.
- Support investigative sites toward completion and appropriate submission of all required clinical trial documents prior to site initiation.
- Coordinate Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
- Support overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications and sharing pertinent information with clinical trial team members and investigative sites.
- Assist clinical trial teams to ensure audit/inspection readiness at each site and internally.
- Enter and maintain required documentation in study specific databases.
- Responsible for the set-up of the Trial Master File, investigator study file binders and regulatory document collection.
- Support user acceptance testing, monitor and review Electronic Data Capture (EDC) reports and data listings, and discuss findings with CRA.
- Coordinate and plan investigator meetings, site training, and other company functions.
- Interacts with internal and external personnel involved in clinical research, including investigative site personnel, as appropriate.
- All ad-hoc duties as assigned.
Skills And Qualifications
- BA or higher and 1-2 years of clinical study experience, or 3+ years of related experience.
- Excellent written, verbal, and interpersonal communication skills, as well as a command of English.
- Strong proficiency in Microsoft Office.
- Knowledge of FDA guidelines, regulations and/or Good Clinical Practice strongly preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kathleen McGurk at (+1) 2674358600 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.