Principal Clinical Research Associate - Hepatitis

Company:	Gilead Sciences, Inc. Company Profile \| Current Opportunities (151)
Job Location(s):	Foster City
Employment Term:	Regular
Employment Type	Full Time
Start Date:	As soon as possible
Starting Salary Range:	Not Provided
Required Experience:	Open
Related Categories:	Healthcare - Practitioner/Technician

Position Description

Job Posting Title:	Principal Clinical Research Associate - Hepatitis
Requisition Number:	4927
Country:	US
State:	California
Job Location:	Foster City
Functional Area:	CLINICAL
Position Type:	Regular
Full-Time / Part-Time:	Full-Time
Shift:	Days
Specific Responsibilities:	This position is located in Foster City, California (SF Bay Area) supporting the clinical trials team for Gilead's Hepatitis franchise.
Essential Duties and Job Functions:	Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas. 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. Assists 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. Assists 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. Travel is required.
Knowledge, Experience and Skills:	Excellent verbal, written, interpersonal and presentation skills are required. Working knowledge and experience with Word, PowerPoint and Excel. Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials. 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. Typically requires a BS or BA in a relevant scientific discipline and minimum 4 years direct CRA experience in the pharmaceutical industry or equivalent.