Under the limited direction of Sports Medicine Physicians, formulates, designs, writes, and obtains funding for sports medicine research. Analyzes drafts of research proposals, summarizes and presents recommended research proposals to team. Promotes research ideas and projects to the sports medicine team. Acts as liaison between sports medicine department and collaborating hospitals and sponsors for research purposes. Coordinates and supervises projects as directed. Conducts follow-up contacts with patients for continued data acquisition. Coordinates entire study enrollment process: pre-procedure testing, patient consenting,, randomization process, patient education and so forth. Acts as liaison for all study patients between the facility and physician.
Oversees compliance with regulatory issues and documentation related to investigational device exemption (IDE) and investigational new drug (IND) clinical trials conducted by the department, as well as humanitarian-use devices utilized in the Sports Medicine Laboratory.
Provides support to physicians, sports medicine fellows and residents in study protocol development, regulatory documentation, and protocol procedures. Oversees study procedures and maintains study documentation in accordance with established Good Clinical Practice (GCP) guidelines, Code of Federal Regulations (CFR) Title 21-regulations, and applicable statute(s). Prepares and submits necessary documentation to DMC Research Review and Institutional Review Board (IRB) for approval prior to initiation of study, as well as ongoing reporting. Oversees completion of case report forms and query resolutions for sponsoring agencies in order to facilitate prompt and full payment of agreements and to ensure the goals of time, cost, and quality are met. In collaboration with study investigator(s) and in a manner consistent with the Declaration of Helsinki and Health Insurance Portability and Accountability Act (HIPAA), assures the protection of the patientâ��s rights and safety. Reports adverse events according to DMC, IRB, Sponsor, and FDA guidelines. Monitors patient safety in collaboration with study investigators. Acts as liaison between sponsors and the site, coordinating trial initiations, monitoring research and ancillary staff to assure protocol and recording compliance. Facilitates external monitoring and auditing of research activities.
Assists in data collection, analysis of results, and preparation for presentation or submission for publication. Provides support to supplementary projects that advance the goals of the department and the institutionâ��s mission, vision, and values.
Participates in the teaching of students, residents and physician extenders in their elective rotations in the Department of Physical Medicine and Rehabilitation.
Participates in continuing medical education programs.
Participates in faculty committees as appropriate.
1. PhD in Biomedical Engineering.
2. Two years of experience in clinical research.
3. Published research.
Job: Therapy and Rehabilitation
Primary Location: Detroit, Michigan
Facility: Detroit Medical Center Shared Services
Job Type: Full-time
Shift Type: Rotate
Employment practices will not be influenced or affected by an applicantâ��s or employeeâ��s race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other legally protected status. Tenet will make reasonable accommodations for qualified individuals with disabilities unless doing so would result in an undue hardship.