Clinical Research Associate 3

Job description

Job responsibilities

• Contribute to all clinical research activities to ensure the successful management of clinical studies.
• Maintain and track clinical study data and help in investigator qualification and selection, scrutiny of potential patient recruitment, and overall study status/progress throughout the life of a study.
• Manage site start-up/activation process, including: Heavy contribution to the preparation of study-related documents (protocols, case report forms (CRFs) or eCRFs, draft informed consent forms (ICF) and complete…
• Organizing IRB/EC submissions and applicable regulatory documentation with follow-through to ensure successful outcomes.
• Amends clinical study documents (ICF, CRFs, Monitoring Plan, etc…) as needed and helps clinical sites with institutional review board submission as necessary.
• Perform on-site and/or remote site qualification visits, site initiation visits, interim monitoring visits, and site close-out visits.
• Conduct clinical study monitoring to ensure regulatory and protocol compliance and overall data accuracy in accordance with the study clinical monitoring plan.
• Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites to ensure regulatory and protocol compliance and overall accuracy.

Job requirements

• Previous experience implementing, helping and managing medical device trials. Significant knowledge of clinical and/or outcomes research study design
• Possess advanced knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR Part 11, 50, 54, 812 and other applicable regulations
• Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
• Clinical research/clinical trial management certification/education preferred
• Prior experiences working in a clinical setting is preferred
• Excellent ability to interact with physicians and other professionals inside and outside the company.
• Excellent experience in protocol and ICF development, writing clinical section(s) for regulatory submission.
• Experience negotiating clinical research contracts and budgets.