Clinical Research Coordinator 1

Core Responsibilities

• Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols.
• Maintains enrollment procedures according to the protocol.
• Covers routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
• Performs moderate to complex research tests/experiments and adapts procedures for quality improvement under supervision.
• Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
• Affirms adverse events, including those reported by study participants.
• Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
• Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
• Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
• Knows the contents and maintenance of study-specific clinical research regulatory binders.
• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
• Adheres to University and unit-level policies and procedures and safeguards University assets.

Department Specific Functions

• Community Engagement and Recruitment: Plan, organize, and participate in community outreach activities to support research recruitment objectives.
• Develop and maintain relationships with community partners and stakeholders to enhance participant enrollment.
• Study Coordination and Management: Coordinate all aspects of research studies, including both interventional and observational projects.
• Manage participant-related activities, such as recruitment, screening, obtaining informed consent, conducting assessments, scheduling follow-ups, and processing reimbursements.
• Serve as a liaison between sponsors or Clinical Research Organizations and the Principal Investigator.
• Oversee the maintenance of essential study documents, including regulatory binders, correspondence, case report forms, and data files.
• Ensure adherence to Good Clinical Practice (GCP) guidelines and promptly report any protocol deviations.
• Operational Support and Communication: Work independently and collaboratively to coordinate study logistics and meet deadlines under pressure.
• Adapt to flexible working hours, including evenings, nights, and weekends, as necessary to support study activities.

Qualifications

• Bachelor’s degree in relevant field
• Minimum 1 year of relevant experience
• Skill in completing assignments accurately and with attention to detail
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines
• Ability to process and handle confidential information with discretion
• Ability to work evenings, nights, and weekends as necessary
• Commitment to the University’s core values
• Ability to work independently and/or in a collaborative environment