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

Job Title:

Research Area Specialist Lead/Senior Underfill

Research Manager, Center for Disability Health and Wellness (CDHW) Department:
Physical Medicine and Rehabilitation CDHW Appointment Type:
Full-time, term-limited position

The Department of Physical Medicine and Rehabilitation and the Center for Disability Health and Wellness (CDHW) seek 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 in-person position 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.

The successful candidate will manage IRBMED submissions, ORIOS processes, data use agreements, data sharing activities, data collection and quality monitoring, and research data systems such as REDCap.

In addition, this role will supervise and train research staff, providing guidance and oversight related to data collection, data entry, regulatory documentation, and study operations to ensure the timely, accurate, and compliant conduct of research across projects. Candidates should possess demonstrated experience with human subjects research, psychosocial research methods, regulatory processes, and University of Michigan research systems, along with exceptional organizational skills and attention to detail.

1. Oversight of Regulatory and Compliance Processes

Provide senior-level oversight for regulatory, compliance, and administrative processes across multiple research projects.

Responsibilities include:

• 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.
• Overseeing and coordinating data sharing to ICPSR or other identified repositories.
• Identify compliance risks and recommend process improvements to support efficient and compliant research operations.

2. 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.

Responsibilities include:

• 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.

3. Supervision of Research Staff

Provide supervision, training, and operational guidance to research staff supporting multiple projects.

Responsibilities include:

• 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…