Clinical Research Manager - Rubin Institute for Advanced Orthopedics
Req #: 41281
Job Category: Management & Supervisory
Shift: Day shift
Department: RIAO ICLL Research - 8750
Exciting opportunity in our world renown Rubin Institute for Advanced Orthopedics. The Clinical Research Manager is 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. The Clinical Research Manager 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. The Clinical Research Manager develops and annually updates research agenda, actively solicits funding, and assists principal investigator(s) in writing grant proposals for funding of research. The Clinical Research Manager manages fiscal operations associated with research activities and clinical trials and performs related duties within one's scope of professional practice. This position has oversight of departmental compliance with complex governmental and institutional policies regulating research involving human subjects. This role serves as liaison between the research staff and the sponsors, collaborators, and regulatory agencies.
The Rubin Institute for Advanced Orthopedics is home to some of the world's most renowned orthopedic surgeons who provide state-of-the-art orthopedic services for children and adults. Its programs include the International Center for Limb Lengthening, the Center for Joint Preservation and Replacement, the Center for Diabetic Limb Preservation and the Center for Hand and Upper Extremity Surgery, among others. The Rubin Institute is located at Sinai Hospital and Northwest Hospital, and has grown to include office locations in Catonsville, Eldersburg, Ellicott City, Mt. Airy, Owings Mills, Timonium, Westminster and White Marsh. This position is located at Sinai Hospital.
Requirements: Seasoned professional knowledge equivalent to a Master's degree, Master's Degree related to life sciences, public health/health administration required, knowledge in more than one discipline, working knowledge of GCP/ICH/FDA guidelines and the clinical development process, at least 7 years of clinical research experience, management experience strongly preferred, Microsoft Office Suite, basic computer skills, Cerner, Healthstream, IDX, standard office equipment, medical terminology, critical thinking skills, statistical software, PACS and de-identifying software, American Heart Association CPR Certification required, and Certified Clinical Research Coordinator Certificate required.