Clinical Study Associate

Job Description: Provide operational support for delivery of assigned studies or programs on time and within budget through both  Responsibilities include: Review required regulatory, financial, and legal documents from study sites for quality and accuracy. Track receipt of regulatory documents from study sites and submit to appropriate departments for approval of drug shipment. Interact with sites to resolve regulatory and financial document discrepancies. Assist in reporting and tracking of study budget spend, including processing study invoices. Order, assemble, distribute, manage and track inventory of study conduct tools and non-drug clinical supplies. Set up, obtain, and maintain sponsor regulatory, legal, and financial files per SOP. Assist in planning and facilitating study meetings (Investigator, CRO, Coordinator); assemble materials for study meetings; and attend meetings as needed to provide support. Assist in providing paper/electronic documentation to support appendices for Clinical Study Reports. Maintain study/site information in GSK database systems. Coordinate mass mailings/faxes to study sites. Minimum requirements: High School Diploma plus two years experience in pharmaceutical industry or health related field Ability to work effectively within interdisciplinary teams Ability to effectively handle competing priorities Computer proficiency in a variety of databases and software applications Knowledge of study processes and procedures, including FDA regulations Education:High School or equivalent Reference Code:3021689 Email:Apply by Email