Program / Project Support Coordinator II
Hiring Department
Department of Radiology
Position Summary
This position is responsible for the day-to-day management and execution of clinical research studies and protocols. It oversees participant recruitment and enrollment, regulatory compliance, study implementation, data collection, and coordination of protocol requirements. The Study Coordinator works closely with the Principal Investigator (PI), research team, clinical staff, and sponsoring agencies to ensure studies are conducted in accordance with institutional, federal, and regulatory guidelines.
Key Responsibilities
Participant Recruitment & Enrollment
- Recruit, screen, and enroll study participants in accordance with protocol eligibility criteria.
- Determine participant eligibility through diagnostic criteria, interviews, observations, and data analysis.
- Develop informed consent packets and conduct consent discussions with participants and families.
- Explain study purpose, diagnostic procedures, and treatment plans to address participant and family concerns.
Study & Protocol Management
- Implement and manage all phases of assigned studies and research protocols.
- Ensure strict compliance with study guidelines and regulatory agency requirements.
- Establish and maintain accurate record-keeping systems.
- Monitor participant progress and assess outcomes throughout study participation.
- Analyze, investigate, and report adverse events in accordance with regulatory requirements.
- Determine when physician notification is required, when participant inclusion should be paused or stopped, and when protocol adjustments may be necessary.
- Resolve IRB and protocol management issues and recommend corrective actions as needed.
- Serve as liaison between the research team and funding/sponsoring agencies.
Clinical & Data Responsibilities
- Ensure timely completion of all protocol requirements including assessments, lab testing, procedures, and treatments.
- Schedule and coordinate participant visits to maintain protocol compliance.
- Collect and process research specimens in accordance with environmental health and safety standards.
- Perform study-required procedures such as vital signs, specimen collection, and processing (training provided as needed).
- Review research supply inventory and monitor expiration dates regularly.
Regulatory Compliance
- Create, maintain, and update regulatory documentation to ensure full compliance.
- Prepare and submit IRB applications, amendments, personnel change forms, and continuing review reports.
- Complete required clinical trial regulatory documents.
- Ensure adherence to HIPAA policies and institutional research standards.
- Maintain current Institutional and CITI training certifications.
- Acquire and apply knowledge of institutional, state, and federal research regulations and guidelines.
Collaboration & Professional Conduct
- Foster a positive, efficient, and professional research environment.
- Communicate and collaborate consistently with clinic personnel, departmental leadership, and research teams.
- Contribute to team initiatives and process improvements.
Additional Responsibilities
Perform other duties as assigned.
Shift
Monday – Friday, 8:00 a.m. – 5:00 p.m.
Minimum Qualifications
A Bachelor's degree or an equivalent combination of education and experience and 2 years of experience from which comparable knowledge and skills can be acquired is necessary.
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