Clinical Research Coordinator 3

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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, including maintaining delegation of authority logs, deviation logs, adverse event logs for all studies.

• Assists PIs and study team with screening, recruitment, including informed consent of participants per protocol guidelines.

• Assists PIs and study team with scheduling and contacting study participants for appointments as needed.

• Assists PIs and study team with data collection, data entry and completing standard operating procedures for quality assurance reviews of data as needed.

• Assists PIs and study team with monitoring and tracking of study visits per protocol guidelines.

• Maintains required CITI Research Certifications and RSQA education for research support staff as mandated by the University and Supervisor.

• Assists PIs and study team with essential documentation including maintenance of study binders, shadow records, and record reviews for study specific data collection per protocols.

• Develops, verifies, and implements procedures to accomplish research goals.

• Implements research protocol and monitors participant adherence to protocol.

• Recruits participants for research studies following the specified recruitment guidelines. Conducts an informed consent interview in various settings with potential participants. Completes all study required forms according to study protocol. Schedules patients to return for follow-up data collection according to protocol directions. Responsible for verifying accurate study and research data, documentation and quality control, and abstracts medical record information as needed by study protocol.

• Ensures that all data is collected, and data entered in a timely manner according to project timetable.

• Ensures data quality assurance and responds to data queries from sponsor.

• Responsible for regulatory oversight, to include preparing and submitting initial study requests, annual reviews and modifications to the Institutional Review Board (IRB), while maintaining consent forms and sponsor correspondences, and notifying the IRB of protocol amendments, safety reports and serious adverse events, etc. in compliance with applicable regulations.

• Participates in all sponsor required training, meetings and/or conference calls. Complies and maintains current with Federal, State and University policies regarding Humans Subjects Research and protection. Prepares specimens for submission to lab, including labeling of specimens and preparation of request forms. Assists PI to compile study information for any reporting required for IRB, sponsor or department.

• Establishes and maintains logs/progress reports to track both currently enrolled as well as follow-up patients/participants. Maintains drug accountability records for study drugs.

• Determines data to be collected and develops forms for collecting/summarizing data.

• Maintains and assists clinical research computer database and enters data onto case reports and/or into database as appropriate. Ensures data integrity and consistency in computer database and written records.

• Completes corrections/queries required at audits/monitor visits and acts to correct deviations as needed.

• Updates appropriate agencies (such as sponsors, IRB, etc.) regarding status of research project.

• Provides in-service education to staff and patients/participants about research protocols.

• Maintains database of department, providing research training and support, ensuring CITI certification and relevant trainings are up to date.

• Attends University of Miami research related education and trainings as appropriate.

• FDA experience highly desired/preferred

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

• 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.

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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 - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

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