Clinical Research Associate 3

About the job

Job Description

Primary Function of Position

The Clinical Research Associate will play a key role in proactively helping the conduct of pre-market and post-market clinical studies to ensure compliance with all the regulatory requirements. The ideal candidate will have a thorough knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR part 812, 50, 54, and other applicable regulations. As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies (pre-market or post-market studies) with minimal supervision. The candidate will be required to work closely with clinical study managers, clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, contribute to clinical study reports, or help the development of clinical publications. The candidate is also expected to have experience reviewing, interpreting, and summarizing clinical literature.

Essential Job Duties

• 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 checklists, able to help clinical trial agreements and budget negotiation, clinical monitoring plan).
• 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.
• Serve as the main liaison to participating clinical trial sites, focusing on data entry, query resolution, investigational device tracking and accountability, and study conduct oversight at the participating clinical sites.
• Partner with data management to help the data cleaning process.
• Drive review of safety events and partner on developing narrative and reporting as needed.
• Develop and manage study trial master file and maintain study documentation and clinical trial management system (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.)
• Track, process and manage site payments and help in study financial tracking by developing tracking tools as necessary.
• Assist the Clinical Study Manager on study scoping activities, including, but not limited to, the development of pre-study questionnaires, study design, and surgeon/site selection.
• Help site audits and site audit preparation in anticipation of site inspections.