University of Miami
Overview
Clinical Research Coordinator 3 (A) role at University of Miami. The Clinical Research Coordinator 3 (A) serves as an experienced clinical research professional responsible for planning, implementing, monitoring, and evaluating multiple clinical research protocols. This role manages multiple studies’ daily operations, conducts study coordination from protocol development through study close-out according to regulatory/sponsor guidelines, ensures study integrity, and mentors less experienced coordinators. The incumbent monitors adherence to research standards and regulatory guidelines, works with study team members and staff/faculty/site personnel to ensure participant safety and protocol compliance, manages study-related administrative tasks, and coordinates study activities and personnel. Note:
This description reflects typical duties and may be expanded to include other duties as necessary. Core Responsibilities
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 addressing ethical conflicts arising during protocol implementation and refers conflicts to the Research Ethics Team as needed. Organizes and manages site visits and internal/external auditing activities as assigned. Coordinates research team meetings; ensures effective communication across the team. Ensures synchronization of study visits/procedures/clinical tests with data collection schedules and time-points; manages progress of study participants through the protocol; expedites overall study progression. Coordinates information for research reports, peer-reviewed publications, and disseminates findings to clinical personnel, professional audiences, and stakeholders. Follows the fundamental requirements of all international, national, and local regulatory bodies. Maintains required skills and mandatory training in safety, responsible conduct of research, continuing education, and research competencies. Adheres to University and unit-level policies and safeguards University assets. Department Specific Functions
The Fetal Surgery Program seeks an experienced Clinical Research Coordinator III to advance our research portfolio. The ideal candidate will be motivated, adaptable to a dynamic environment, and capable of managing regulatory documentation and submissions to IRB and FDA. This role ensures compliance and supports the integrity of clinical research efforts. Assist PIs and study team with regulatory IRB submissions, continuing reports, and protocol modifications, including maintaining delegation of authority logs, deviation logs, and adverse event logs for all studies. Assist with regulatory tasks including screening, recruitment, informed consent, scheduling, data collection, data entry, and quality assurance reviews of data as needed. Maintain required certifications (e.g., CITI) and RSQA education for research support staff as mandated. Maintain study documentation, binders, shadow records, and data collection per protocol. Develop, verify, and implement procedures to accomplish research goals; monitor participant adherence to protocol. Recruit participants, conduct informed consent interviews, schedule follow-ups, verify data accuracy, and ensure quality control. Ensure timely data collection and data quality; respond to sponsor data queries. Regulatory oversight includes preparing and submitting IRB initial requests, annual reviews, and modifications; maintain consent forms and sponsor communications; notify IRB of amendments and safety events. Participate in sponsor-required trainings and meetings; ensure compliance with human subjects protections; prepare specimens for submission as needed; assist in compiling study information for IRB/sponsor reporting. Maintain logs to track enrolled and follow-up participants; manage drug accountability records; develop data collection forms; manage and ensure data integrity in databases. Address audit/monitor findings and implement corrective actions; update sponsors/IRB on study status; provide in-service education to staff and patients/participants about protocols. Maintain department research training and certification records (e.g., CITI); participate in University research education and trainings. FDA experience is highly desired. This list of duties is not all-inclusive and may be expanded to include other duties as necessary. Qualifications
Core Qualifications Bachelor’s degree in a relevant field Current Clinical 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 problems Ability to manage workload under pressure and meet deadlines Ability to handle confidential information with discretion Ability to work independently and/or in a team 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 is South Florida’s only university-based health system, committed to leading-edge patient care supported by research and medical education. Our physicians represent more than 100 specialties and sub-specialties with extensive patient encounters annually. We are an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants are protected from discrimination based on Federal law. Job Status:
Full time Employment Type:
Staff Pay Grade:
A10 Seniority level:
Mid-Senior level Job function:
Research, Analyst, and Information Technology Industries:
Higher Education
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Clinical Research Coordinator 3 (A) role at University of Miami. The Clinical Research Coordinator 3 (A) serves as an experienced clinical research professional responsible for planning, implementing, monitoring, and evaluating multiple clinical research protocols. This role manages multiple studies’ daily operations, conducts study coordination from protocol development through study close-out according to regulatory/sponsor guidelines, ensures study integrity, and mentors less experienced coordinators. The incumbent monitors adherence to research standards and regulatory guidelines, works with study team members and staff/faculty/site personnel to ensure participant safety and protocol compliance, manages study-related administrative tasks, and coordinates study activities and personnel. Note:
This description reflects typical duties and may be expanded to include other duties as necessary. Core Responsibilities
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 addressing ethical conflicts arising during protocol implementation and refers conflicts to the Research Ethics Team as needed. Organizes and manages site visits and internal/external auditing activities as assigned. Coordinates research team meetings; ensures effective communication across the team. Ensures synchronization of study visits/procedures/clinical tests with data collection schedules and time-points; manages progress of study participants through the protocol; expedites overall study progression. Coordinates information for research reports, peer-reviewed publications, and disseminates findings to clinical personnel, professional audiences, and stakeholders. Follows the fundamental requirements of all international, national, and local regulatory bodies. Maintains required skills and mandatory training in safety, responsible conduct of research, continuing education, and research competencies. Adheres to University and unit-level policies and safeguards University assets. Department Specific Functions
The Fetal Surgery Program seeks an experienced Clinical Research Coordinator III to advance our research portfolio. The ideal candidate will be motivated, adaptable to a dynamic environment, and capable of managing regulatory documentation and submissions to IRB and FDA. This role ensures compliance and supports the integrity of clinical research efforts. Assist PIs and study team with regulatory IRB submissions, continuing reports, and protocol modifications, including maintaining delegation of authority logs, deviation logs, and adverse event logs for all studies. Assist with regulatory tasks including screening, recruitment, informed consent, scheduling, data collection, data entry, and quality assurance reviews of data as needed. Maintain required certifications (e.g., CITI) and RSQA education for research support staff as mandated. Maintain study documentation, binders, shadow records, and data collection per protocol. Develop, verify, and implement procedures to accomplish research goals; monitor participant adherence to protocol. Recruit participants, conduct informed consent interviews, schedule follow-ups, verify data accuracy, and ensure quality control. Ensure timely data collection and data quality; respond to sponsor data queries. Regulatory oversight includes preparing and submitting IRB initial requests, annual reviews, and modifications; maintain consent forms and sponsor communications; notify IRB of amendments and safety events. Participate in sponsor-required trainings and meetings; ensure compliance with human subjects protections; prepare specimens for submission as needed; assist in compiling study information for IRB/sponsor reporting. Maintain logs to track enrolled and follow-up participants; manage drug accountability records; develop data collection forms; manage and ensure data integrity in databases. Address audit/monitor findings and implement corrective actions; update sponsors/IRB on study status; provide in-service education to staff and patients/participants about protocols. Maintain department research training and certification records (e.g., CITI); participate in University research education and trainings. FDA experience is highly desired. This list of duties is not all-inclusive and may be expanded to include other duties as necessary. Qualifications
Core Qualifications Bachelor’s degree in a relevant field Current Clinical 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 problems Ability to manage workload under pressure and meet deadlines Ability to handle confidential information with discretion Ability to work independently and/or in a team 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 is South Florida’s only university-based health system, committed to leading-edge patient care supported by research and medical education. Our physicians represent more than 100 specialties and sub-specialties with extensive patient encounters annually. We are an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants are protected from discrimination based on Federal law. Job Status:
Full time Employment Type:
Staff Pay Grade:
A10 Seniority level:
Mid-Senior level Job function:
Research, Analyst, and Information Technology Industries:
Higher Education
#J-18808-Ljbffr