Ophthalmology Clinical Trials Coordinator (Multi-site)

University of Michigan; Ann Arbor (MI); Hybrid; USD 60,000 - 85,000; Full time

Benefits offered by this job

Excellent medical, dental and vision

2:1 retirement match

Job summary

The De Lott Research Group in the Department of Ophthalmology and Visual Sciences at the University of Michigan Kellogg Eye Center seeks a detail-oriented Research Area Specialist - Intermediate to support prospective, multi-institutional clinical studies focused on chronic ocular pain and other neuro-ophthalmic conditions.

You will assist with participant recruitment, regulatory and data-management activities, study procedures and workflows, and collaboration with investigators and staff across

Qualifications

• Bachelor's degree in health science, public health, psychology, neuroscience, clinical research, nursing, social science, or 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 and exceptional communication skills.
• Ability to work independently and as part of a team.
• Experience with MS Word, Excel, Power Point, Outlook or equivalent.
• Experience with creating databases in RedCap or willingness 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.

Responsibilities

• 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 elevate issues to the Principal Investigator and study team members as appropriate.
• Assist with preparation of study reports, presentations, manuscripts, and other dissemination products.
• 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.
• 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.
• 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.

Skills

Excellent organizational skills

Excellent communication skills

Ability to learn new skills

Teamwork / working with others

Education

Bachelor's degree in health science, public health, psychology, neuroscience, clinical research, nursing, social science, or related field

Tools

REDCap

MS Office Suite (Word, Excel, PowerPoint, Outlook)

Job description

The De Lott Research Group in the Department of Ophthalmology and Visual Sciences at the University of Michigan Kellogg Eye Center seeks a detail-oriented Research Area Specialist - Intermediate to support prospective, multi-institutional clinical studies focused on chronic ocular pain and other neuro-ophthalmic conditions.

You will assist with participant recruitment, regulatory and data-management activities, study procedures and workflows, and collaboration with investigators and staff across