Sr. Clinical Research Associate

Job Description Primary Function of the Position The Senior Clinical Research Associate will play a vital role in supporting pre-market clinical studies of investigational drugs for the Fluorescence Imaging group, ensuring full compliance with regulatory requirements. The ideal candidate will have in-depth knowledge of clinical research in drug trials, including Good Clinical Practice (GCP) and relevant US regulations for human subjects. As a member of the Clinical Fluorescence Imaging team, this individual will collaborate with key stakeholders and contribute to the successful execution of pre-market clinical studies, working independently with minimal supervision. The role will involve close coordination with Senior Clinical Project Managers, the Head of the Fluorescence Imaging Clinical Team, and other team members. The Sr CRA will also travel frequently to Investigational Sites to conduct co-monitoring along with the assigned Field CRA(s)/Monitor(s) assigned to specific investigational sites by the CRO. Essential Job Duties Contribute to all clinical research activities to ensure the successful start-up and management of clinical studies through FDA approval. Maintain and track clinical study data monitored and help in Investigator, Sub-Investigators qualification and selection, training, scrutiny of potential patient recruitment, and overall study status/progress throughout the life of a study. Co-Management of site start-up/activation process, including heavy contribution to the preparation of study-related documents and complete checklists, able to help with clinical trial agreements and budget negotiation, finalization of clinical monitoring plan, training materials, etc. Assist with eCRFs/EDC system, CTMS, eTMF and imaging Core Labs. Assist with review of IRB submissions, consents and applicable regulatory documentation with follow-through to ensure successful outcomes. Assist with amendments clinical study documents (ICF, CRFs, protocols, Monitoring Plan, study tools, etc.) as needed and assist clinical sites with institutional review board submission if necessary. Experienced with performing on-site and/or remote site qualification visits, site initiation visits, interim co-monitoring visits, and site close-out visits with or without the CRO. Conduct clinical study co-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. Assist and support participating clinical trial sites, to ensure timely data entry, data integrity, query resolution, investigational drug accountability, and study conduct oversight at the participating clinical sites. Partner with data management (CRO) to help the data cleaning process. Assist with the development and management of study electronic clinical trial master file (eTMF) 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.) Assist the Sr Clinical Project Manager on study scoping activities, including, but not limited to, the development of pre-study questionnaires, study design, and surgeon/site selection. Assist Investigational sites with site audits preparation in anticipation of site inspections as well as assist during actual audits. Assist with internal and external audits preparation as well as during actual audits. Assist with SIV preparation and presentations. Assist with Investigators meetings preparation and presentations, including logistics and planning. #J-18808-Ljbffr Intuitive