Mission Statement
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components: patient care, education and research that together enhance our contribution to society.
Job Summary
The Michigan Institute for Clinical & Health Research (MICHR) is the home of the University of Michigan's Clinical and Translational Science Award from the National Institutes of Health. MICHR is part of a national, collaborative consortium that is focused on bringing more health solutions to all people more quickly by advancing translational science. The field of translational science aims to build an evidence base of scientific and operational approaches that improve the efficiency, effectiveness, and impact of translational research across a range of diseases and conditions. MICHR has the unique charge of examining the translational research ecosystem at a systems level to determine where common pitfalls exist; developing novel solutions to these challenges; demonstrating their effectiveness; and disseminating improvements widely. MICHR is a dynamic organization that serves as a hub of innovation and experimentation to advance research in the science of translation and accelerate the realization of interventions that improve human health.
MICHR is seeking a Research Compliance Specialist Senior to provide clinical research monitoring and regulatory compliance support for investigator-initiated, single-site FDA-regulated studies. This position will conduct on-site and remote monitoring visits, review clinical trial and regulatory documents, perform source data verification, assess investigational product accountability, evaluate AE/SAE documentation, and prepare detailed monitoring reports in accordance with GCP/ICH-GCP, federal regulations, institutional standards, study protocols, and monitoring plans.
The Research Compliance Specialist Senior will serve as a regulatory compliance subject matter expert, advising investigators and study teams on FDA requirements, GCP, IRB expectations, and institutional policies. This role will work with study teams to resolve monitoring findings and action items, support audit preparation, and escalate non-compliance concerns as appropriate. The position will also assist with the development and delivery of educational materials and contribute to SOPs, tools, templates, and resources that promote consistent and compliant clinical research practices.
Responsibilities*
Clinical Research Monitor Activities - 80%
Provide services related to Clinical Study Monitoring activities for investigator-initiated single-site FDA-regulated research projects. This may include, but is not limited to the following:
- Critically review submission documents and clinical trial documents, such as clinical protocols, informed consent documents, and study materials, to ensure compliance with regulatory requirements. Conduct on-site and remote monitoring visits to assess compliance with GCP, ICH-GCP, protocol requirements, federal regulations, and institutional standards.
- Perform source data verification and review CRFs/electronic data capture systems for accuracy, completeness, and timeliness
- Prepare detailed monitoring visit reports documenting site, pharmacy, laboratory, and site performance
- Review Investigational product (drug and device) accountability. This includes visiting the Research pharmacy online and in person, as well as ensuring participants are assigned to the correct randomization schedule.
- Serve as a subject matter expert on regulatory compliance, advising study teams and investigators on FDA regulations, GCP, and updated or current policies, guidelines, and compliance related to research.
- Assess and review AE/SAE documentation and reporting per the IRB and Protocol guidelines
- Assist study teams (as time allows) to prepare for internal audits and guide teams in remediating findings and preventing recurrence
- Interact with study teams to ensure complete and accurate study data per the Monitoring Plan, adherence to local and federal regulations, and protocol-specific instruction.
- Review source documents and compare this to the data entered in the study database (when there is an electronic database). This includes (but is not limited to) reviewing eligibility, primary outcomes, subject recruitment, enrollment, protocol deviations, stopping rules, and withdrawals as written in the study Monitoring Plan.
- Perform clinical trial monitoring visits and produce reports documenting Site Initiation Visits, Interim Monitoring visits, Close Out Visits, and Pharmacy or other visits
- Work with the study teams to resolve Action items and monitoring queries
- Ensure essential regulatory documentation is collected, maintained, and current
- Communicate regulatory issues or concerns with the Michigan IND/IDE Investigator Assistance Program (MIAP) Project Lead as appropriate.
- Escalate non-compliance with the SMM Lead and the MIAP Program Director
Education and Consultations ? 15%
- Works with other program staff to develop and present educational materials, to ensure uniformity of review and compliance with standard operating procedures and applicable federal and state regulations.
- Assist in providing regulatory education and training to investigators, sponsor-investigators, clinical research coordinators, project managers, and other research/regulatory personnel
Medical Writing and Editing- 5%
- Creating and revising SOPs, development of tools, documents, and resources for the purposes of creating standard practice, templates
Required Qualifications*
- Bachelor's degree with 5 years of clinical trial experience, or an equivalent combination of education and work experience in an academic research setting
- Minimum 3 years of experience in monitoring clinical trials in an academic or industry setting, including monitoring compliance with research regulations
- Knowledge of FDA regulations, policies, and guidance related to investigational drugs and devices
- Excellent written and verbal communication skills, including the ability to effectively communicate complex regulatory and compliance concepts
- Demonstrated strong analytical and organizational skills, including a high level of accuracy and attention to detail while exercising good judgment
- Proven ability to set priorities, exercise initiative, manage multiple projects simultaneously, and meet/negotiate deadlines
- Ability to work effectively with diverse teams as well as independently
- Demonstrated efficient organizational skills and ability to effectively solve problems and implement solutions to improve processes
- Excellent interpersonal and conflict resolution skills
- Demonstrated ability to take initiative in process improvement and function in a self-directed manner
- Understanding of GCP and applicable regulatory guidelines
Desired Qualifications*
- Experience with query management and electronic data capture systems
- Experience in monitoring both device and drug studies
- Experience supporting sponsor-investigator-initiated FDA-regulated clinical trials preferred.
- Certification in RAC, SOCRA (CCRP), ACRP (CCRA or CCRC), or equivalent clinical research certification
Why Join Michigan Medicine?
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.
What Benefits can you Look Forward to?
- Excellent medical, dental and vision coverage effective on your very first day
- 2:1 Match on retirement savings
Modes of Work
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
Background Screening
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third-party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Application Deadline
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled any time after the minimum posting period has ended.
U-M EEO Statement
The University of Michigan is an equal employment opportunity employer.