Manager, Clinical Research
Manager, Clinical Research
The Clinical Translational Research Site is currently seeking a full time Manager, Clinical Research to work on-site in Miami.
The Manager, Clinical Research (A) oversees the development of clinical trials and research programs that support the overall mission of the University. This role is also responsible for the independent execution of regulatory-related decisions/strategies and coordinates work with study managers and other relevant team members to assure the fidelity of study protocols and data collection.
Department Specific Functions- Supervise and Lead Clinical Research Coordinators: Oversee the daily activities of the CTRS Clinical Research Coordinators, providing guidance, mentorship, and performance feedback to ensure adherence to study protocols and regulatory requirements.
- Ensure Compliance with Regulatory Requirements: Monitor all clinical research activities to ensure compliance with institutional, federal, and international regulations, including Good Clinical Practice (GCP), Institutional Review Board (IRB) protocols, and FDA guidelines. Responsible for maintaining the CTRS central regulatory binder.
- Manage Study Protocol Implementation: Work together with the CTRS Clinical Research Coordinators to ensure that clinical trials are conducted according to the approved study protocols, including CTRS in-services, site initiation visits, participant recruitment, consent, data collection, and monitoring, to maintain the integrity of the research.
- Develop and Implement Standard Operating Procedures (SOPs): Create and update SOPs, ensuring all CTRS Clinical Research Coordinators follow consistent, efficient, and compliant practices.
- Train and Onboard New Staff: Provide comprehensive training to new CTRS Clinical Research Coordinators and other team members, covering regulatory requirements, clinical trial processes, data collection and best practices.
- Monitor Study Progress and Troubleshoot Issues: Regularly review study progress, identify potential barriers to timely enrollment, data collection, or compliance, and work with the team to address and resolve issues in a timely manner.
- Collaborate with Principal Investigators (PIs): Under the guidance of the CTRS Director, serve as the liaison between the CTRS Clinical Research Coordinators and PIs, ensuring clear communication and alignment with the study goals, timelines, and expectations.
- Ancillary Reviews: Work together with the CTRS Clinical Research Nurse Manager and CTRS Director to review and respond to ancillary review requests in a timely manner.
- Budget and Resource Management: Assist the CTRS Director in developing budgets for clinical trials, ensuring that studies have budgeted for the necessary tools, materials, and staff to conduct studies efficiently.
- Prepare for Audits and Inspections: Lead preparation for internal and external audits or inspections, ensuring the research unit is fully prepared and that all documentation is up-to-date and in compliance with applicable standards.
- Productivity: Work with the CTRS Director to develop, implement and optimize metrics to drive the decision-making process for CTRS Clinical Research Coordinator Service line needs and track productivity.
- Performs other duties as assigned.
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.
MINIMUM QUALIFICATION
- Bachelor's Degree in relevant field required.
- Master's degree in relevant field preferred.
- SOCRA or ACRP certification is required.
- Five (5) years of experience managing an extensive clinical research program or project is required.
- This position is onsite.
Knowledge, Skills and Attitudes:
- Exceptional leadership and communication skills with experience in clinical research development.
- 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.
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. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status: Full time
Employee Type: Staff