Clinical Research Associate - CRA
We are looking for a Clinical Research Associate in Frederick, MD.
Assists clinical project manager(s) in the management and coordination of assigned clinical research studies, in compliance with FDA regulations, ICH GCP guidelines, and SOPs. May serve as a liaison with CROs to ensure quality service and clinical study conduct. Evaluates and participates in selection of consultant, CROs, and study sites to conduct clinical research activities. Ensures that the clinical study sites, CROs, and other vendors are in compliance with GCPs and relevant SOPs. Tracks activities associated with clinical trials. Under direction of a clinical project manager, prepares necessary clinical documents and study-related documents, such as assigned portions of a protocol, protocol amendments, informed consent guidelines, assigned portions of investigator brochures, transfer of regulatory obligations (TORO) forms, and study operations manuals. May assist in preparing and reviewing Statements of Work (SOWs) and Requests for Proposals (RFPs). Provides direction to CRO Clinical Research Associates. Has primary responsibility for collection of essential regulatory and other study-specific documentation related to assigned projects. Responsible for updating assigned SOPs pertaining to management of clinical studies and Clinical Research Department activities according to GCP. Participates in the review of Investigator Brochures, study reports, safety reports, statistical tables and data listings, and clinical sections of Annual Reports, INDs, marketing applications (NDAs/BLAs), and briefing documents. Work with internal staff, consultants and medical writers.
Minimum Bachelor's Degree (BS, BA, RN) or equivalent in biological or related science field. Minimum of 6 or more years experience in clinical research and project management with at least 2 years in-house or field clinical monitoring (CRA) experience. Full-time position. Travel required <10%
Required Skills for Clinical Research Associate - CRA Job:
- CLINICAL RESEARCH MONITOR
- CLINICAL TRIALS
- GCP/ICH
- PROTOCOL DESIGN
- BIO/PHARMACEUTICAL
Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.
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