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CLINICAL RESEARCH ASSOCIATE SENIOR CLINICAL RESEARCH ASSOCIATE Mission Statement: Be directly involved in the design, implementation, and monitoring of clinical trials. Responsibilities: • Assist in the review of protocols, informed consents, case report forms, monitoring tools, clinical study reports and other study-related materials. • Maintain frequent contact with and work effectively with investigators, site coordinators, and vendors. • Prepare and track required documentation from clinical sites. • Conduct initiation meetings, site qualification visits, routine monitoring visits, and close-out visits and assist in the organization of investigator's meetings. • Track study progress and ensure data integrity. • Identify, document and resolve deviations or deficiencies relating to site's study data and/or conduct. • Correctly transmits CRFs to data management and ensures prompt resolution of data queries as necessary. • Assure site compliance with SAE reporting process as well as reconcile SAE/AE listings. • Complete a monitoring report accurately and completely and complete site letters for pre and post monitoring visit that correlate with monitoring reports. • Assure regulatory compliance of investigational sites with company SOPs, FDA and ICH guidelines. • BS in a scientific discipline or health related field. • Minimum 1 year of experience as a monitor in a CRO, pharmaceutical or biotechnology company. |