This experienced clinical research professional provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. The role manages daily operations for several studies, coordinates activities from protocol development to close-out according to guidelines, ensures study integrity, and mentors less experienced coordinators. The incumbent monitors adherence to research standards, regulatory guidelines, and operational procedures, collaborates with study teams to ensure participant safety, manages administrative and human resources tasks, facilitates information flow, and orchestrates study activities and personnel.
Responsibilities
Coordinate the implementation of multiple complex clinical research protocols
Develop SOPs and templates with guidance from the PI/Clinical Research Manager
Oversee and facilitate eligibility screening and study recruitment activities; implement strategies to increase accrual
Manage sample processing, packing, and shipping according to protocol, applicable standards, and regulations
Plan and operationalize strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations
Develop and implement preventive/corrective actions
Develop, disseminate, and assure adherence to study-related clinical research best practices/scientific manuals
Assume leadership in protocol implementation and study progress, keeping investigators apprised of study progress
Provide leadership in identifying and working through ethical conflicts arising during protocol implementation and refer these conflicts to the Research Ethics Team for consults as needed
Organize/manage site visits and internal/external auditing activities as assigned
Coordinate research team meetings; assure communications across-the-board
Assure synchronization of study visits/procedures/clinical tests with data collection schedules, established time-points; manage progress of study participants through protocol; expedite overall study progression
Coordinate the compilation of information needed for research reports; peer-reviewed publications; develop strategies to disseminate information to clinical personnel, professional audiences and stakeholders
Follow the appropriate fundamental requirements of all international, national, and local regulatory bodies
Maintain requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies
Adhere to University and unit-level policies and procedures and safeguard University assets
Provide 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
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Act as a senior mentor and leader to junior research staff, guiding protocol execution, troubleshooting complex operational challenges, and escalating issues when appropriate
Coordinate and lead research team meetings, fostering clear, consistent communication across investigators, coordinators, regulatory staff, and ancillary departments
Design and maintain standardized documentation tools to ensure consistent study conduct across the PCCSM research portfolio
Oversee eligibility screening, recruitment, and enrollment strategies; develop and implement targeted methods to optimize participant accrual and retention
Ensure synchronization of study visits, clinical procedures, diagnostics, and data collection according to protocol-specified timepoints
Lead safety oversight activities, including monitoring, documentation, reporting, and follow-up of unanticipated problems, adverse events, and protocol deviations
Maintain and strengthen global partnerships with industry sponsors, CROs, and academic collaborators, serving as a trusted operational lead and liaison for PCCSM-led trials
Requirements
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 4 years of relevant experience
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
Benefits
Comprehensive benefits package including medical, dental, tuition remission and more
About the Company
UHealth-University of Miami Health System is South Florida's only university-based health system, providing patient care powered by research and medical education at the Miller School of Medicine. As an academic medical center, it serves South Florida, Latin America and the Caribbean. Its physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. The tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care.
