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

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

Job Title: Research Area Specialist Lead/Senior Underfill

Working Title: 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.

Responsibilities*

Key Responsibilities

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 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.

Required Qualifications*

Research Area Specialist Lead:

• Master's degree in recognized field of science or learning which is directly related to teh duties of the position. 

• 6 or more years 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. 
• Operationalize study design elements and develop protocol documents. Train study staff in study implementation.
• 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 recognized field of science or learning which is directly related to the duties of the position i
•  5-6 years 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. 
• Operationalize study design elements and develop protocol documents. Train study staff in study implementation.
• 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.

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.

Work Schedule

This is a full-time position working 40 hours per week. The schedule will generally be 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.

Work Locations

This position is intended to be fully in person. The selected candidate will be expected to work on-site in accordance with departmental expectations and University of Michigan policies.  Local and regional travel is required for community engagement, meetings, outreach events, conferences, and related activities.

Underfill Statement

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

Additional Information

• This is 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 not available, your appointment will terminate and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct. The statements included in this description are intended to describe the general nature and level of work assigned to this classification and should not be interpreted as all-inclusive.

Additional Information

Knowledge, Skills, and Abilities

• Strong understanding of human subjects research protections and regulatory compliance. 
• Ability to interpret and apply institutional research policies and sponsor requirements. 
• High level of accuracy and attention to detail in regulatory and data-related work. 
• Strong project management and organizational skills. 
• Ability to create efficient workflows and improve research operations. 
• Ability to train and mentor staff with varying levels of research experience. 
• Strong problem-solving skills and sound judgment. 
• Comfort working across multiple projects with competing priorities. 
• Commitment to ethical research conduct, participant confidentiality, and data integrity.

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 Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.