The position reports into the Clinical Operations team for the HIV franchise. The role is located at the corporate office in Foster City - San Francisco Bay Area.
Essential Duties and Job Functions:
Knowledge, Experience and Skills:
- With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
- Assures site compliance with the routine protocol and regulatory requirements and quality of data. May resolve routine monitoring issues.
- Participate in the setting and updating of study timelines. Assists in CRO or vendor selection. With guidance from supervisor coordinates CROs or vendors.
- May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports.
- Participate in the review of routine data and preparation of safety, interim and final study reports, and resolution of data discrepancies.
- May participate in abstract presentations, oral presentations and manuscript development. Interfaces with individuals in other functional areas to address routine study issues.
- May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants. Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
- BS or BA in a relevant scientific discipline and minimum 4 years direct CRA experience in the pharmaceutical industry or equivalent.
- Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Working knowledge and experience with Word, PowerPoint and Excel.
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
- Ability to develop tools and processes that increase measured efficiencies of the project.
- Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
- Must have a general understanding of functional issues and routine project goals from an organizational perspective.
Gilead Sciences has biotech balms for infectious diseases, including hepatitis, HIV, and infections related to AIDS. The company's HIV...