Clinical Research Coordinator 3 (A)

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 The University of Miami/UHealth Department OBGYN has an exciting opportunity for a full-time Clinical Research Coordinator 3  to work in Miami, FL. The Clinical Research Coordinator 3 (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

• The Fetal Surgery Program is seeking an experienced Clinical Research Coordinator III to play a crucial role in advancing our research portfolio. The ideal candidate will be highly motivated, have a flexible work schedule and adaptable, ready to thrive in a dynamic environment that may require a flexible work schedule. We are particularly looking for someone with high attention to detail, a proven experience in managing regulatory documentation and submissions to entities such as the Institutional Review Board (IRB) and the Food and Drug Administration (FDA). This role is essential for ensuring compliance and supporting the integrity of our clinical research efforts.

• Assist PIs and study team with regulatory IRB submissions, continuing reports, and modifications of protocols, in