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The Department of Clinical Translational Research Site is currently seeking a full time Manager, Clinical Research Nursing to work in Miami. The Manager, Clinical Research Nursing manages day-to-day clinical research operations and study coordination duties, from protocol development and initiation to study close-out. The Manager, Clinical Research Nursing provides leadership and training/mentorship in planning, implementing, monitoring, coordinating, and evaluating clinical research studies. The incumbent assesses, plans, implements, and evaluates study participants’ clinical care in clinical research studies as well as clinical research policies/ procedures that protect participants in clinical research studies.
CORE RESPONSIBILITIES:
1. Develops, implements, and evaluates study-specific protocols, SOPs, and templates that can be adopted/adapted for future studies; defines study procedures, tests, and data collection/recording; and manages day-to-day operations of multiple complex clinical research studies.
2. Determines, assures, and develops strategies to assure appropriate clinical involvement in clinical research studies, crossing clinical discipline boundaries as research consultant, clinical specialty-specific clinical research expert, and/or liaison among study personnel, clinical staff, and service departments.
3. Conducts/oversees research teams’ clinical assessments, follows-up on findings, reviews medical records/lab tests for potential/enrolled study participants.
4. Identifies and assures full adherence to relevant mandatory competency standards (e.g., environmental, safety, diversity) throughout study planning, implementation, and follow-up.
5. Develops and assures accuracy, organization, and integrity of clinical research documentation and protocol workflows. Identifies clinical safety implications during study development.
6. Supervises other clinicians’ administration of study drugs/device/materials according to practice standards and clinical credentials. Ensures licensed and trained personnel administer study products according to protocol, safety standards, and credentialing mandates.
7. Plans, implements, and evaluates strategies to effectively monitor, document, report, and follow-up on protocol deviations, unanticipated occurrences, adverse effects and evaluates and manages preventive/corrective actions.
8. Oversees administrative duties related to study personnel including orientation, assuring core competencies, certification mandates, safety/responsible conduct of research education; conducts performance reviews.
9. Assumes leadership in clinical meetings, Grand-Rounds, conferences, and seminars as clinical research study liaison.
10. Leads efficient clinical research nursing team meetings; assures effective communications; provides leadership in problem solving logistical challenges to assure study objectives are achieved according to protocol and projected timeline. Assures seamless collaboration with clinical services and departments in protocol planning, implementation, evaluation.
11. Collaborates synchronization of study visits, procedures, and clinical tests with data collection schedules, established time-points; effectively advances study participants through protocol; expedites overall study progression with minimal clinical disruption.
12. Assesses, documents, promotes, and problem solves study participants’, research team members’, and clinical personnel’s adherence to clinical research procedures, protocol, and timeline.
13. Leads effort to effectively adapt clinical plan to meet study requirements with least clinical disruption/drawback. Develops, implements, and evaluates effectiveness of SOP/decision trees to guide evaluation of clinical test results relative to the study, determines need for follow-up, assures appropriate follow-up on abnormal parameters.
14. Builds research competency of team and clinical collaborators; promotes career development. Develops, presents, and evaluates practice-focused training modules and CEUs.
15. Adheres to University and unit-level policies and procedures and safeguards University assets.
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
Education:
Bachelor’s degree in Nursing (BSN) from an accredited School of Nursing.
Certification and Licensing:
Valid Florida Registered Nurse Licensure (RN)
Basic Life Support Certification (BLS)
Experience:
Minimum 5 years of relevant experience
Knowledge, Skills and Attitudes:
• Knowledge of business and management principles.
• Ability to direct, manage, implement, and evaluate department operations.
• Ability to establish department goals, and objectives that support the strategic plan.
• Ability to effectively plan, delegate and/or supervise the work of others.
• Ability to lead, motivate, develop, and train others.
DEPARTMENT ADDENDUM
The Clinical Research Nurse Manager will be responsible for overseeing day-to-day clinical research unit functions and study coordination. This includes managing protocol development, implementation, and study initiation while adhering to regulatory and sponsor guidelines to ensure study integrity. The role involves planning and implementing strategies to ensure compliance with clinical research standards and regulations, as well as obtaining study approvals. The manager will also facilitate collaboration among study teams, clinical personnel, staff, faculty, and study sites to prioritize participant safety and maintain protocol and data integrity. Additionally, the manager will handle study-related administrative tasks and ensure seamless communication and coordination of study activities and personnel.
Department Specific Functions
• Lead a team of clinical research nurses and medical assistants, utilizing coordinating, coaching, facilitating, and planning techniques. Assure communication and promote collaboration among research teams, clinical services, data coordinating centers, compliance monitors, sponsors, investigators’ academic departments, and research administration.
• Provide direct participant care as per protocol, support protocol implementation and data collection, and ensure best practices for protecting human subjects.
• Ensure compliance with study protocols, perform clinical research tests, administer investigational medications, and document study procedures and data as per physician treatment orders.
• Ensure all research activities comply with FDA and GCP guidelines. This includes maintaining regulatory documents when needed and ensuring site compliance with research protocols. Mandatory (current) CITI and COI training before participating in any research-related procedure.
• Oversee data collection, documentation, entry, and reporting, ensuring data integrity and consistency throughout the study visits.
• Develop and manage research request study budgets, overseeing personnel and equipment resources.
• Conduct ongoing quality control audits to ensure compliance with research protocols and maintain accountability for the unit's processes.
• Provide continuous clinical research nursing training and coaching, ensuring the research team is appropriately credentialed and trained. Provide CTRS staff onboarding and facilitate processes with JHS onboarding of clinical research nursing.
• Collaborate with internal and external parties, including sponsors, principal investigators, and study participants, to ensure smooth study operations within the clinical research units.
• Assures optimal equipment operation, maintenance/calibration, and timely supply/materials procurement.
• Responsible for UHT ancillary review committee meetings and approvals.
• Assist in determining the feasibility of study protocols pertinent to department support and staffing. Qualitative solid skills and knowledge of study design.
• Meet with department staff weekly to provide leadership and update inquiries.
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.
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Job Status:
Full time
Employee Type:
Staff
Pay Grade:
H14
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