- Wayne State University (Detroit, MI)
- Research Compliance Monitor , IRB Wayne...For-Cause Audits as requested by the Institutional Review Board Committee or Human Research ... compliance . Submit monitoring reports to the Human Research Protection Program Administration and to the Institutional...and protocol violations and direct to committee Chair, individual Institutional Review Board , institutional… more
- Henry Ford Health System (Southfield, MI)
- …informed consent processes, and human subjects protection principles. + Coordinate with the Institutional Review Board ( IRB ) to facilitate efficient ... role serves as the central point of coordination for research education, IRB and IACUC compliance..., Reporting, and Continuous Improvement + Monitor compliance with institutional research policies… more
- Henry Ford Health System (Detroit, MI)
- …the established research protocol are met and in compliance with the Institutional Review Board ( IRB ) and sponsor guidelines. Identifies and ... throughout the study protocol participation. Coordinate/participate I the Institute Review Board ( IRB ) process for...in contract and budget negotiations with the sponsor and research office. Monitor budgets to ensure that… more
- Wayne State University (Detroit, MI)
- …are expected to have hands-on experience with GxP standards (Good "X" Practices), Institutional Review Board ( IRB ) submissions, documentation control, ... systems, and site practices. Ensure compliance with all clinical research activities with FDA, EMA, ICH-GCP, and institutional regulatory requirements.… more
- University of Michigan (Ann Arbor, MI)
- …developing and writing Abstracts/Manuscripts and/or Clinical Trials Protocols. Support the preparation for IRB audit and monitor : + Assist in the preparation of ... Clinical Research Technician/Assistant Apply Now **Job Summary** This position...+ Act as liaison between study team and sponsors, IRB , federal, state, and University officials and other regulatory… more
- Wayne State University (Detroit, MI)
- …Assurance and Quality Control: Implement quality control measures. o Ensure data integrity and compliance with IRB research protocols. Work with others on ... and amendments. o Ensure all data collection methods strictly follow the approved research design and methodology. o Monitor data collection progress, and seek… more
- University of Michigan (Ann Arbor, MI)
- Clinical Research Assistant Apply Now **How to Apply** A cover letter is required for consideration for this position and should be attached as the first page of ... to this position. **Job Summary** The Program for Clinical Research in Dermatology (PCRiD) is seeking an experienced, positive,...etc. and assisting with skin biopsies. + Track and monitor participants? condition and test results during the course… more
- University of Michigan (Ann Arbor, MI)
- …reliance agreements and communications between enrolling sites. + Maintain regulatory ?les, monitor compliance with Good Clinical Practice, ICH + guidelines, and ... and study progress, reporting on milestones. Regulatory Coordination & Compliance + Independently prepare and manage IRB ...Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. (Please review… more
- Corewell Health (Southfield, MI)
- …after hire Or + CRT-Healthcare Research Compliance , Certified (CHRC) - CCB Compliance Certified Board SHHG Org Integrity and Compliance within 1 year ... compliance committees. + Works with operational leaders and Compliance COEs to develop and monitor internal...after hire Or + CRT-Healthcare Research Compliance , Certified (CHRC) - HCCA Health… more
- Otsuka America Pharmaceutical Inc. (Lansing, MI)
- …guidance, ICH/GCP, and Otsuka SOPs. * Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed ... selection of CROs, outside vendors (eg, central labs, central IRB , IVRS, etc.), and investigative sites. * Provide leadership...* Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast. *… more
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