To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03581

About our client Our client is a biotechnology company based in Richmond, CA. They focus on the research, development and commercialization of products for gene therapy regulation. The new technologies are used to fight diseases, like diabetes and HIV. With a strong pipeline of products in pre-clinical and clinical stages, this is an exciting time to join a fast-paced environment! Position Location CRA II California Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist in designing, planning and implementing clinical research projects 2) Facilitate the negotiation of site contracts and budgets, manage and calculate site payments 3) Assist in developing protocols, Investigator brochures, case report forms, informed consents, study manuals and study budgets 4) Perform site visits including site qualification, initiation, monitoring and close-out visits 5) Co-monitor with regional monitors and review monitoring reports 6) Ensure adherence to the protocol providing for accurate data collection, documenting drug accountability and compliance with federal regulations 7) Represent the company in a professional manner 8) Establish and maintain good relationships with investigators and study site personnel 9) Maintain frequent site contact 10) Prepare and track required documentation and manage study supplies at clinical sites 11) Oversee and track project progress at assigned sites (patient status, safety/adverse events, CRF completion, payments, study drug supply, regulatory documents) 12) Assist in planning Investigator meetings 13) Review data listings on an ongoing basis 14) Assist in preparing interim study analyses, annual reports and clinical study reports Requirements 1) BA/BS in Nursing, Pharmacy, Life Sciences or a health-related discipline 2) 2 to 3 years of pharmaceutical industry experience including direct site management 3) Thorough knowledge of GCP, ICH and FDA regulations 4) Strong organizational, communication (both written and verbal) and interpersonal skills 5) Ability to function independently or as part of a team 6) Self-motivated, assertive and detail-oriented individual with ability to multi-task and work effectively in a fast-paced environment 7) Willingness and ability to travel (30 – 40%)