Clinical Programs Coord III
About The Position
This role involves the independent coordination of day-to-day operations for multiple clinical and translational research studies. Key responsibilities include participant screening, enrollment, informed consent, study visits, retention activities, and follow-up assessments, while ensuring protocol adherence and participant safety. The position requires maintaining source documentation, study records, and participant tracking systems, and coordinating study activities across various settings (clinical, community, home-based, remote). A significant part of the role includes preparing and managing IRB submissions, amendments, continuing reviews, reportable events, and study closures, as well as overseeing logs and inspections for biospecimens labs. The role also supports sponsor projects for the Claude D. Pepper Center and IOA specific projects, and provides customer service to investigators utilizing IOA assets. Additionally, the position is responsible for developing study timelines, operational plans, manuals of procedures, and workflow processes, as well as developing and monitoring budgets. It involves coordinating sponsor communications, monitoring visits, audits, and regulatory inspections, and tracking institute and study milestones, deliverables, enrollment targets, and reporting requirements. The role also assists investigators with protocol planning and implementation. Furthermore, the position involves setting up systems to track and monitor institute activities, managing electronic research databases, conducting quality control reviews, generating reports on enrollment, retention, and study performance, and maintaining data integrity and compliance with data-sharing principles. Engagement and research participant relations include developing and implementing recruitment and retention strategies, representing the Institute at community outreach events, and establishing relationships with clinics, community organizations, and research participants. Finally, the role provides functional supervision and training to research staff, and assists with grant applications, progress reports, publications, and center-wide initiatives.
Requirements
- Bachelor's degree in an appropriate area and four years of relevant experience; or an equivalent combination of education and experience.
Nice To Haves
- Experience coordinating NIH-funded clinical, translational, or population health research.
- Experience working with older adult populations.
- Experience with project management.
- Experience with electronic data capture systems, and research databases.
- Experience in clinical research.
- Integrity, careful attention to detail; ability to maintain confidentiality, demonstrate professionalism and respect for subjects’ rights and individual needs; willing to learn and maintain skills in accordance with HIPAA regulations and Good Clinical Practice guidelines.
- Experience mentoring research staff, trainees, and students on job duties.
- Current CCRC (Certified Clinical Research Coordinator), Good Clinical Practice (GCP) or other relevant certifications.
Responsibilities
- Independently coordinate day-to-day operations of multiple clinical and translational research studies.
- Conduct participant screening, enrollment, informed consent, study visits, retention activities, and follow-up assessments.
- Ensure protocol adherence and participant safety.
- Maintain source documentation, study records, and participant tracking systems.
- Coordinate study activities across clinical, community, home-based, and remote settings.
- Prepare and manage IRB submissions, amendments, continuing reviews, reportable events, and study closures.
- Oversee logs and inspections for biospecimens lab.
- Support sponsor projects – Claude D. Pepper Center and IOA specific projects.
- Provide customer services to investigators utilizing IOA assets.
- Develop study timelines, operational plans, manuals of procedures, and workflow processes.
- Develop and monitor budgets for Institute and specific projects.
- Coordinate sponsor communications, monitoring visits, audits, and regulatory inspections.
- Track institute and study milestones, deliverables, enrollment targets, and reporting requirements.
- Assist investigators with protocol planning and implementation.
- Set up systems to track and monitor institute activities.
- Manage electronic research databases.
- Conduct quality control reviews of research studies.
- Generate enrollment, retention, and study performance reports.
- Maintain data integrity and compliance with data-sharing principles.
- Develop and implement participant recruitment and retention strategies.
- Represent the Institute at community outreach events and participant registries.
- Establish and maintain relationships with clinics, community organizations, and research participants.
- Provide functional supervision and training to research assistants, students, OPS staff, volunteers, and trainees.
- Assist with grant applications, progress reports, publications, and center-wide initiatives.
- Coordinate research meetings, advisory committees, and collaborative activities.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
