Exciting opportunity in our world renown Rubin Institute for Advanced Orthopedics. Responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensures completion of study deliverables, typically works on studies with moderate to high complexity, and proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required. Develops research proposals and manages on-going clinical research activity in concert with principal investigator(s), submits and coordinates ARB/IRB applications and renewal reports, conducts data collection activities, statistically analyses data, collaborates in publication process regarding research results, and serves as a technical consultant to other staff involved in research initiatives with the RIAO, at all locations. Develops and annually updates research agenda; actively solicits funding and assists principal investigator(s) in writing grant proposals for funding of research. Manages fiscal operations associated with research activities and clinical trials. Performs related duties within one's scope of professional practice. Oversight of departmental compliance with complex governmental and institutional policies regulating research involving human subjects. Serve as liaison between the research staff and the sponsors, collaborators, and regulatory agencies.
Requirements: Seasoned professional knowledge; equivalent to a Master's degree; knowledge in more than one discipline. Degree related to life sciences, public health/health administration. Working knowledge of GCP/ICH/FDA guidelines and the clinical development process. 7 + years of experience. Microsoft Office Suite; Basic computer skills; Cerner; Healthstream; IDX ; Standard Office Equipment; Medical terminology; Nursing Process skills based on MD Nurse Practice Act; Critical thinking skills; Medical equipment; Statistical software; PACS and De-identifying software; American Heart Association CPR Certification and Certified Clinical Research Coordinator Certificate