Clinical Research Coordinator 1 at University of Miami, Florida

Clinical Research Coordinator 1 (A)

The department of Medicine has an exciting opportunity for a full-time Clinical Research Coordinator 1 (A) to work onsite on the UHealth campus. The Clinical Research Coordinator 1 (A) serves as an experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studies' daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study's integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.

Core Job Functions

• Coordinates the implementation of multiple complex clinical research protocols.
• Develops SOPs and templates with guidance from the PI/Clinical Research Manager.
• Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.
• Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.
• Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Develops and implements preventive/corrective actions.
• Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.
• Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
• Provides leadership in identifying and working through ethical conflicts arising during protocol implementation and refers these conflicts to the Research Ethics Team for consults as needed.
• Organizes/manages site visits and internal/external auditing activities as assigned.
• Coordinates research team meetings; assures communications across-the-board.
• Assures synchronization of study visits/procedures/clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.
• Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.
• Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
• 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

• Provides daily operational oversight for the clinical research team, ensuring effective coordination of study activities, adherence to best practices, and consistent application of SOPs across trials.
• Acts as a senior mentor and leader to junior research staff, guiding protocol execution, troubleshooting complex operational challenges, and escalating issues when appropriate.
• Coordinates and leads research team meetings, fostering clear, consistent communication across investigators, coordinators, regulatory staff, and ancillary departments.
• Designs and maintain standardized documentation tools to ensure consistent study conduct across the PCCSM research portfolio.
• Oversees eligibility screening, recruitment, and enrollment strategies; develops and implements targeted methods to optimize participant accrual and retention.
• Ensures synchronization of study visits, clinical procedures, diagnostics, and data collection according to protocol-specified timepoints.
• Leads safety oversight activities, including monitoring, documentation, reporting, and follow-up of unanticipated problems, adverse events, and protocol deviations.
• Maintains and strengthens global partnerships with industry sponsors, CROs, and academic collaborators, serving as a trusted operational lead and liaison for PCCSM-led trials.

Core Qualifications

• Bachelor's degree in relevant field
• Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months
• Minimum 1 year of relevant experience

Knowledge, Skills and Attitudes:

• Skill in collecting, organizing and analyzing data.
• Ability to recognize, analyze, and solve a variety of problems.
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
• Ability to process and handle confidential information with discretion.
• 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 tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.