Clinical Regulatory Coordinator (Cambridge)

Clinical Regulatory Coordinator

s www.globalchannelmanagement.com jobopeningsjobs(at)globalchannelmanagement.co mClinical Regulatory Coordinator needs 1-4 years of clinical research experience in academic and or industry settingsClinical Regulatory Coordinator requires oncology experience strongly Bachelor s degree or higher in life sciences health sciences nursing pharmacy or other related field Working knowledge of ICH GCP and FDA guidelines Knowledge of and direct experience with Trial Master Files. Prior regulatory operations experience desirable. Fundamental knowledge of conduct of clinical trials is preferred. Strong focus on teamwork attention to detail excellent organizational skills. Must have ability to prioritize and the ability to work in a multi-task environment. Must be able to work independently. Must maintain confidentiality of information demonstrate good decision-making and judgment. eTMF (e.g. Veeva) experience preferred. Clinical Regulatory Coordinator duties Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities. Maintain Trial Master Files. Act as a liaison between the Site IRBs and Clinical team to resolve regulatory queries and concerns. Prepare and assist in submission of protocol amendments IND safety reports consent form changes and continuing reviews