In this role, the selected candidate will ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
In this role, the successful candidate will be responsible for the coordination, administration and regulatory compliance of clinical trial documentation and investigational product traceability for the conduct of clinical trials during product research and development of ophthalmic medical device.
In this role, you will audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.
In this role, you will be responsible for research include: research; program development; statistical analyses related to all phases of preparation of scientific papers, presentations, and grant applications; staff professional development at project level; and off-site research activities with a variety of populations including persons with identified developmental disabilities.
In this role, the selected candidate will assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.