Research Area Specialist Senior/Intermediate

Research Area Specialist Senior/Intermediate

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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 Department of Cardiac Surgery at Michigan Medicine is seeking a Research Area Specialist to serve as a subject matter expert and central resource for its broad clinical and outcomes research enterprise. This role supports the full lifecycle of research studies, offering strategic and operational partnership from study conception through closeout, while ensuring alignment with University, sponsor, and federal requirements. In close collaboration with investigators, research teams, administrators, staff, students, and institutional partners, the Research Area Specialist provides guidance and support on study design, protocol development, regulatory affairs, research applications, data governance, investigator-initiated studies, and daily research operations. This individual will serve as an advisor, identifying opportunities to improve processes, navigating moderate to complex challenges, and promoting the quality and integrity of research practices across the department. The successful candidate will be expected to apply sound judgment and foster collaborative relationships with stakeholders at all levels.

Responsibilities*

Research Consultation and Study Development

• Serve as the department's primary resource for the planning, development, implementation, and administration of clinical and outcomes research studies.
• Consult with faculty investigators, fellows, residents, and research personnel regarding study design, methodology, feasibility, and implementation strategies.
• Provide guidance throughout the research study lifecycle, including study startup, conduct, amendments, continuing review, and study closure.
• Assist investigators with protocol development, protocol amendments, investigator-initiated studies, and research documentation.
• Support proposal development, budget preparation, and administrative requirements associated with sponsored and investigator-initiated research.
• Identify operational challenges affecting research studies and develop practical solutions to improve efficiency, quality, and compliance.

Regulatory Affairs and Research Compliance

• Coordinate regulatory activities for research studies, including preparation, submission, and management of IRB applications, protocol amendments, continuing reviews, and study closures.
• Conduct departmental pre-reviews of research submissions to ensure completeness and compliance prior to institutional review.
• Provide guidance regarding applicable federal regulations, institutional policies, Good Clinical Practice (GCP), and ethical standards governing research.
• Coordinate submission and management of Data Use Agreements (DUAs), Unfunded Agreements (UFAs), Memoranda of Understanding (MOUs), and other Proposal Approval Forms (PAFs).
• Monitor regulatory timelines and ensure required approvals remain current throughout the duration of research studies.
• Maintain current knowledge of evolving federal regulations, sponsor requirements, University policies, and emerging research administration best practices.

Research Operations and Systems Administration

• Administer departmental access to research applications and institutional systems, including EMERSE, MiChart, REDCap, and other related platforms.
• Provide consultation regarding research data access, security requirements, and institutional data governance policies.
• Maintain accurate study records, regulatory documentation, sample inventories, and research tracking databases.
• Assist with study-related accounts payable and accounts receivable activities as needed, including tracking invoices, payments, and related documentation.
• Coordinate communications and operational activities with clinical research units and institutional partners.
• Serve as the primary liaison for internal research collaborations requiring data and/or biospecimen sharing.

Education and Training

• Serve as a departmental subject matter expert for research onboarding and required certifications, providing guidance to faculty, staff, students, fellows, volunteers, and temporary personnel.
• Maintain educational resources and training materials related to research processes, regulatory requirements, institutional policies, and best practices.
• Coordinate departmental participation in programs such as the Undergraduate Research Opportunity Program (UROP), including student onboarding and administrative oversight.
• Mentor research personnel and provide ongoing consultation to promote consistent research practices, operational efficiency, and compliance across the department.
• Represent the department on institutional committees and workgroups related to research administration and compliance.

Required Qualifications*

• Bachelor's degree in health sciences, biological sciences, public health, research administration, or another related field.
• Senior Level: 5-8 years of progressively responsible experience supporting research.
• Intermediate Level: 3-5 years of progressively responsible experience supporting research.
• Experience interpreting and applying federal regulations, sponsor requirements, and institutional policies to complex research activities.
• Experience with research management systems such as REDCap, EMERSE, eResearch, and other related applications.
• Experience preparing grant proposals, research budgets, and sponsor submissions.
• Strong understanding of research data management, documentation standards, and quality assurance practices.
• Excellent written and verbal communication skills with the ability to effectively consult with faculty, researchers, and institutional partners.
• Excellent organizational, analytical, and problem-solving skills.

Desired Qualifications*

• Master's degree in a health sciences discipline or another related field.
• Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), Certified IRB Professional (CIP), or similar professional certification.
• Experience supporting clinical faculty principal investigators within an academic medical center.
• Experience supervising, mentoring, or coordinating the work of research personnel.
• Knowledge of University of Michigan research systems and processes, including eResearch, MiChart, REDCap, EMERSE, and sponsored project administration.

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

• Await You?

• 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.

• Underfill Statement

• This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

• 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 Michi