In-House Clinical Research Associate

Technical Resources International, Inc. - Bethesda, MD

Full-timeEstimated: $53,000 - $74,000 a year
EducationSkills
Review and process essential regulatory documents received from clinical trial sites; request additional information when necessary; respond to protocol and process-related queries; maintain trial master files; and track the process in a centralized Web-based system and/or other databases. Please note, this position will work onsite when not on travel.

Requirements: Bachelor’s degree in life sciences or other health-related field; 0 - 2 years of experience in the clinical research arena; and proficiency with Microsoft Office. Experience with essential regulatory document review/collection and knowledge of applicable FDA ICH/GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO setting (i.e., CRA, Study Coordinator, IRB Coordinator, and Regulatory Coordinator/ Associate/ Specialist). BS degree in health-related field or Licensed Practical Nurse. Experience with IRB submissions (OHRP regulations) is a plus.