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 De Lott Research Group in the Department of Ophthalmology and Visual Sciences at the University of Michigan Kellogg Eye Center is seeking a detail-oriented and highly motivated Research Area Specialist - Intermediate. The RAS will support prospective, multi-institutional clinical research studies focused on chronic ocular pain and other neuro-ophthalmic conditions.
This position will work closely with Principal Investigator Dr. Lindsey De Lott, another clinical research coordinator, co-investigators and research staff at collaborating institutions, and clinical partners. The RAS will support participant recruitment and retention, study visits, regulatory and data-management activities, and the development and execution of protocols and workflows. A key responsibility will be assisting the group's other coordinator with quantitative sensory testing and other portions of study visits as needed.
The successful candidate will be dependable, organized, attentive to detail, and able to manage multiple responsibilities while working independently within established procedures and collaboratively as part of a multidisciplinary team. Strong communication, follow-through, participant-centered professionalism, and the ability to identify and escalate issues appropriately are essential.
We value different perspectives and are committed to fostering a collaborative environment in which every team member can thrive and contribute to our collective success.
Responsibilities*
Project Coordination
- Coordinate day-to-day study startup, study implementation, and study closeout activities in collaboration with the Principal Investigator and research team.
- Lead development and refinement of study procedures, recruitment and participant-facing materials, intervention materials, and other project documentation.
- Develop and maintain study procedures and workflows to support consistent implementation of the research protocol.
- Coordinate activities and communication among research team members and external collaborators.
- Monitor study progress, identify and troubleshoot implementation issues, and escalate issues to the Principal Investigator and study team members as appropriate.
- Assist with preparation of study reports, presentations, manuscripts, and other dissemination products.
Participant Recruitment, Enrollment, and Retention
- Lead and coordinate recruitment and enrollment of study participants along with the study coordinator and research assistants.
- Oversee participant screening, informed consent, and enrollment activities and conduct these activities as needed.
- Coordinate participant tracking, follow-up, and completion of study activities.
- Lead efforts to support participant retention throughout the study.
- Coordinate participant incentives and related participant study processes.
Data Collection and Coordination
- Monitor study activities and research documentation for completeness and adherence to established study procedures.
- Maintain study tracking systems and oversee timely completion of participant research activities.
- Develop and update electronic and paper case report forms, surveys, and data-collection tools using REDCap or other approved systems.
- Support secure data transfer and data harmonization across participating institutions.
- Prepare recruitment, enrollment, retention, data-quality, and study-progress reports for investigators and study teams.
- Help train and support research staff in database use, data entry, data-quality procedures, and discrepancy resolution.
Regulatory Coordination
- Prepare and submit IRB applications, amendments, continuing reviews, reportable events, and study-closure materials with appropriate oversight.
- Coordinate regulatory activities for multi-institutional research, including single-IRB processes, and communication with participating sites when applicable.
- Draft and update informed consent documents, protocols, standard operating procedures, recruitment materials, participant-facing documents, and other study materials.
- Maintain complete and current regulatory binders and essential study documentation in accordance with institutional, sponsor, and Good Clinical Practice requirements.
- Track regulatory approvals, expiration dates, training requirements, delegation logs, and participating-site documentation.
- Maintain required ClinicalTrials.gov records or support designated team members with registration and reporting, when applicable.
- Stay current on relevant regulatory requirements and institutional policies.
- Participate in monitoring visits, audits, and quality assurance activities and help coordinate responses and corrective actions.
Supervision Received
This position reports to Dr. Lindsey De Lott within the Department of Ophthalmology and Visual Sciences at the University of Michigan Kellogg Eye Center.
Supervision Exercised
None.
Required Qualifications*
- Bachelor's degree in health science, public health, psychology, neuroscience, clinical research, nursing, social science, or a related field, or an equivalent combination of related education and experience.
- Minimum of two years of directly related experience in clinical research or clinical trials.
- Exceptional organizational skills
- Exceptional communication skills
- Capacity to learn new skills as the positional needs change.
- Ability to work both independently and as part of a team.
- Experience with MS Word, Excel, Power Point, Outlook or equivalent.
- Experience with creating databases in RedCap or willing to learn
- Experience conducting participant-facing clinical research activities, including recruitment, informed consent, enrollment, study visits, or follow-up.
- Working knowledge of Good Clinical Practice, human-subject protections, informed consent requirements, research documentation, and participant-safety reporting.
- Experience implementing clinical research protocols and following manuals of procedures and standard operating procedures.
- Experience with Institutional Review Board processes and regulatory documentation.
- Ability and willingness to work on-site for participant visits.
- Ability and willingness to learn and perform study procedures after completing required training and competency assessment.
- Flexibility to accommodate occasional study activities outside standard business hours.
Desired Qualifications*
- Four or more years of directly related clinical research experience.
- Experience in ophthalmology, optometry, neurology, pain research, neuroscience, or another participant-facing clinical research setting.
- Experience conducting quantitative sensory testing, psychophysical testing, ophthalmic assessments, or standardized pain assessments.
- Experience coordinating prospective, multi-institutional studies.
- Experience with federally funded or investigator-initiated research.
- Familiarity with single-Institutional Review Board and reliance processes.
- Experience with University of Michigan systems, policies, eResearch, and the Institutional Review Board of Michigan Medicine.
- Familiarity with medical terminology and electronic health record review for research.
- Experience preparing for monitoring visits or audits and responding to data or regulatory findings.
- Experience training or orienting students or research staff to established procedures.
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
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.
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.