Clinical Research Coordinator 1

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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.

Core Functions:

• 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.

Department Specific Functions:

Key responsibilities include:

1. 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.

2. 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.

3. 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.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

Core 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.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

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