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 - 2 years ago
Gilead Sciences has biotech balms for infectious diseases, including hepatitis, HIV, and infections related to AIDS. The company's HIV...