Clinical Document Specialist

Job Description:Position reports to the Clinical Operations Director. The Clinical Document Specialist will:• Contribute intellectual energy, experience, and enthusiasm to the growth and establishment of the essential trial documentation group within clinical operations.• Provide meaningful support to the creation, implementation, maintenance and continued improvement of physical and electronic filing systems for the housing of all essential clinical trial documents.• Oversee the regulatory document collection and submission process within trials to which assigned, ensuring that all investigators are in compliance with 21 CFR, ICH GCP section 8, and CVT's SOPs prior to drug shipment. Ensure that all essential documentation is filed, scanned, and e-archived in a timely manner.• Assist with the conduct of routine audits of clinical site files, to ensure that site regulatory documents are collected, updated and filed appropriately. Partner with CVT's clinical quality assurance group in the routine audits of clinical studies, and clinical site files.• Liase between in-house personnel and site and/or regional personnel within assigned trials to ensure that outstanding investigative site regulatory documents are collected, filed and archived according to department procedures and guidelines, and in compliance with all regulations.• Work closely and collaboratively with clinical program managers and clinical project managers to ensure that trial master file content and format are consistently communicated and adhered to.• Coordinate with clinical program managers and clinical trial managers to develop and update specifications and procedures for the design and format of clinical documents policies and procedures• Support clinical operations director with the development and initiation of departmental regulatory compliance initiatives.

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Job Experience:Four or more years of experience creating and/or maintaining clinical trial filing systems within a pharmaceutical company or CRO.Expertise in ICH GCP Section 8 is essential. Must be highly competent in Microsoft Word, Microsoft XL, and other Microsoft Office Applications. Familiarity with Documentum, Microsoft Access and other electronic document management systems very desirable.Must have exemplary attention to detail and outstanding organizational skills; Ability to work under aggressive timelines and to communicate effectively; Must have high energy level, flexibility, creative problem-solving ability and demonstrated success in working in a fast-paced, team environment. CV Therapeutics, Inc., headquartered in Palo Alto, CA, is a Biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases, the leading cause of death in the United States.CVT offers competitive salaries and an excellent benefits package, including stock options and an employee stock purchase plan. To apply for this position, please go to https://www.cvt.apply2jobs.com Equal Opportunity Employer.