Clinical Research Coordinator 1

University of Miami•Miami, FL

8h•Onsite

About The Position

The University of Miami/UHealth Department of Psychiatry has an exciting opportunity for a full time Clinical Research Coordinator 1 to work in Miami, FL. The Clinical Research Coordinator 1 (CRC 1) will report directly to the Project Manager and serve as the primary point of contact for several PI-initiated studies and sponsored clinical trials. This position requires a proactive and organized individual who is committed to upholding the University’s core values while contributing to the successful execution of research projects.

Requirements

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.

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.
Coordinates 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.
Assists in observing and informing the PI/supervisor of 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.
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.
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.
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.