Research Area Specialist Lead/Senior Underfill (term-limited)

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.

This is a full-time, term-limited position within the Department of Physical Medicine and Rehabilitation and the Center for Disability Health and Wellness (CDHW). The role is intended to be fully in-person, with local and regional travel required for community engagement, meetings, outreach events, conferences, and related activities.

About the Role

The Center for Disability Health and Wellness (CDHW) seeks a detail-oriented and experienced Research Area Specialist Senior to provide operational leadership for multiple grant-funded and non-funded human subjects and psychosocial research projects. This role will oversee regulatory compliance, research operations, data management, and quality assurance activities, ensuring studies are conducted in accordance with University of Michigan, Michigan Medicine, IRBMED, sponsor, and applicable regulatory requirements.

Responsibilities

• Oversight of Regulatory and Compliance Processes
  • Oversee human subjects regulatory submissions, amendments, continuing reviews, adverse event reporting, and study closures through IRBMED and other applicable systems.
  • Manage and monitor ORIOS processes and related institutional requirements for research projects.
  • Ensure research activities comply with University of Michigan, Michigan Medicine, federal, state, sponsor, and institutional requirements.
  • Coordinate and manage regulatory documentation for human subjects research projects.
  • Oversee and coordinate Data Use Agreements including tracking, documentation, and communication with relevant University offices.
  • Assist investigators and project leadership with reporting to sponsors, collaborating institutions, regulatory bodies, and other internal or external entities.
  • Maintain accurate and organized regulatory files, correspondence, approvals, and compliance documentation.
  • Monitor regulatory timelines and ensure required renewals, amendments, and reports are submitted accurately and on time.
  • Oversee and coordinate data sharing to ICPSR or other identified repositories.
  • Identify compliance risks and recommend process improvements to support efficient and compliant research operations.
• Supervision of Data Quality and Data Management Activities
  • Lead data quality, data collection, and data management activities across multiple research projects, ensuring consistency, reliability, accuracy, and security of research data.
  • Supervise and support reliable data collection and entry procedures across studies.
  • Develop, implement, and maintain data collection protocols, data dictionaries, tracking tools, and quality assurance procedures.
  • Provide training to research staff on accurate and consistent data collection, participant tracking, data entry, and documentation practices.
  • Design, build, test, and maintain REDCap databases, surveys, forms, reports, and data export procedures as needed.
  • Monitor data quality through routine audits, validation checks, discrepancy reports, and review of study records.
  • Identify data inconsistencies, missing data, and protocol deviations; work with study teams to resolve issues.
  • Ensure data management practices align with IRB-approved protocols, Data Use Agreements, sponsor requirements, and applicable privacy/security standards.
  • Support preparation of analytic datasets, reports, and summaries for investigators, sponsors, collaborators, and other stakeholders.
  • Collaborate with investigators and analysts to ensure data structures and collection systems meet study aims and reporting needs.
  • Develop and maintain standard operating procedures for data management and quality assurance activities.
  • Promote best practices in secure data handling, confidentiality, and documentation.
  • Develop study timelines and ensure that deliverables are met on time.
• Supervision of Research Staff
  • Supervise research staff, student staff, temporary staff, or other project personnel as assigned.
  • Assign, prioritize, and monitor staff work related to regulatory tasks, data collection, data entry, participant tracking, and study operations.
  • Train staff on study protocols, human subjects requirements, REDCap/data systems, documentation standards, and compliance expectations.
  • Provide ongoing feedback, coaching, and performance support.
  • Assist with onboarding new staff and ensuring completion of required trainings, including human subjects protections and other institutional requirements.
  • Support workflow planning and cross-coverage across projects.
  • Lead or participate in project team meetings, regulatory check-ins, and data quality meetings.
  • Foster a collaborative, detail-oriented, and compliance-focused research environment.
  • Escalate operational, staffing, regulatory, or data quality concerns to project leadership as appropriate.

Qualifications

• Research Area Specialist Lead
  • Master's degree in a recognized field of science or learning directly related to the duties of the position.
  • Six or more years of research experience directly applicable to this position.
  • Experience with data use agreements and related institutional compliance processes.
  • Substantial experience supporting or coordinating human subjects research.
  • Experience with psychosocial, behavioral, clinical, public health, or health services research.
  • Demonstrated experience with and expertise in research regulatory and compliance processes.
  • Knowledge of HIPAA, informed consent requirements, data privacy, and secure research data handling practices.
  • Experience preparing and maintaining IRB submissions and regulatory documentation.
  • Experience with research data collection, data quality monitoring, and data management.
  • Experience developing standard operating procedures, training materials, and quality assurance workflows.
  • Demonstrated expertise with REDCap and similar electronic data capture systems.
  • Experience training staff on data collection, data entry, data quality, protocol implementation, or regulatory procedures.
  • Ability to operationalize study design elements and develop protocol documents.
  • Strong organizational skills and ability to manage multiple projects, deadlines, and priorities simultaneously.
  • Excellent attention to detail and commitment to high-quality documentation.
  • Strong written and verbal communication skills.
  • Ability to work independently and collaboratively with investigators, research staff, sponsors, collaborators, and administrative partners.
  • Demonstrated ability to handle sensitive and confidential information appropriately.
• Research Area Specialist Senior
  • Bachelor's degree or an equivalent combination of education and experience in a recognized field of science or learning directly related to the duties of the position.
  • Five to six years of related experience.
  • Experience with data use agreements and related institutional compliance processes.
  • Substantial experience supporting or coordinating human subjects research.
  • Experience with psychosocial, behavioral, clinical, public health, or health services research.
  • Demonstrated experience with and expertise in research regulatory and compliance processes.
  • Knowledge of HIPAA, informed consent requirements, data privacy, and secure research data handling practices.
  • Experience preparing and maintaining IRB submissions and regulatory documentation.
  • Experience with research data collection, data quality monitoring, and data management.
  • Experience developing standard operating procedures, training materials, and quality assurance workflows.
  • Demonstrated expertise with REDCap and similar electronic data capture systems.
  • Experience training staff on data collection, data entry, data quality, protocol implementation, or regulatory procedures.
  • Ability to operationalize study design elements and develop protocol documents.
  • Strong organizational skills and ability to manage multiple projects, deadlines, and priorities simultaneously.
  • Excellent attention to detail and commitment to high-quality documentation.
  • Strong written and verbal communication skills.
  • Ability to work independently and collaboratively with investigators, research staff, sponsors, collaborators, and administrative partners.
  • Demonstrated ability to handle sensitive and confidential information appropriately.

Desired Qualifications

• Research Area Specialist Lead
  • Doctoral Degree in field of expertise.
  • Familiarity with University of Michigan and/or Michigan Medicine research processes and systems, including IRBMED.
  • Experience supervising research staff.
  • Experience with sponsor reports, progress reports, or other required research reporting.
  • Experience using project management software.
• Research Area Specialist Senior
  • Master's degree in field of expertise.
  • Familiarity with University of Michigan and/or Michigan Medicine research processes and systems, including IRBMED.
  • Experience supervising research staff.
  • Experience with sponsor reports, progress reports, or other required research reporting.
  • Experience using project management software.

Schedule

This is a full-time position working 40 hours per week, generally Monday through Friday during standard business hours. Occasional evening or weekend hours may be required to support community events, conferences, partner meetings, webinars, or other outreach activities.

Additional Information

This is a two-year, term-limited appointment, with the possibility of extension depending on performance and availability of funding. At the end of the stated term, if funds are not available, the appointment will terminate and will not be eligible for Reduction-in-Force (RIF) benefits.