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research compliance spec lead

4 months ago

Ann Arbor, Michigan, United States University of Michigan Full time

RESEARCH COMPLIANCE SPEC LEAD

Summary
The Michigan Clinical Outcomes Research and Reporting Program (MCORRP) is seeking an experienced Research Compliance Specialist Lead to join us as a full-time team member. MCORRP has been performing outcomes research for over 25 years in a variety of patient populations and has made important contributions to improving patient care. Our friendly and collaborative staff and supportive faculty help to create a pleasant and productive work environment.

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.

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
Responsibilities*
Use E-research to prepare and submit new applications, renewals, amendments, adverse events and terminations to the IRB for current MCORRP projects and their substudies.
Collaborate with team members to write and/or amend protocols, agreements, consent forms and other documents as needed for current and new MCORRP projects.
Maintain regular communication and serve as liaison with participating sites and UofM legal/grants offices to renew financial or legal agreements (e.g. DUAs) with participating study sites.
Prepare Proposal Approval Forms (PAF), obtain invoicing information and trouble-shoot issues and delays.
Communicate with sites as part of the Coordinating Center team to receive/maintain current IRB status for participating sites.
Ensure that all MCORRP staff, students and volunteers complete institution specific research training (i.e. PEERRS certification) and are listed on the IRB applications for projects they work on.
Prepare, coordinate, and schedule study meetings as needed and complete study follow-up as needed.
Assist as needed in preparing annual and other reports for MCORRP and various registries.
Abstract data from EPIC EMR and enter data into MCORRP clinical registries
Required Qualifications*
Bachelor's degree and 8 years or more of professional experience in research compliance and/or research
Experience providing regulatory compliance support for clinical studies, including developing, managing, and submitting regulatory documents (IRB applications, protocols, consent forms, agreements, DUAs etc) and preparing/submitting study reports.
Experience coordinating/assisting with clinical research studies, including identifying eligible patients, EMR review and data abstraction/entry, scheduling study meetings, taking meeting notes, and carrying out meeting follow-up tasks as needed.
Experience communicating with other sites as part of multi-center clinical research projects
Excellent organizational and time management skills
Excellent written and verbal communication skills.
Ability to complete work duties independently, with little direct supervision.
Experience working with Microsoft Office products, including Word, PowerPoint, Outlook, and Excel.
Desired Qualifications*
10+ years providing regulatory compliance support for multi-center clinical studies, including developing, managing, and submitting regulatory documents (IRB applications, protocols, consent forms, agreements, etc) and preparing/submitting study reports.
10+ years of experience coordinating/assisting with clinical research studies, including identifying eligible patients, EMR review and data abstraction/entry, scheduling study meetings, taking meeting notes, and carrying out meeting follow-up tasks as needed.
Work Schedule
This position can be full-time onsite at Arbor Lakes or hybrid ( minimum of 1 day/week in office [Tuesdays])

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.