Manager, Clinical Research - Peds ID

University of Florida; Gainesville, Jacksonville (FL, FL); On-site; USD 82,000 - 85,000; Full time

Job summary

University of Florida College of Medicine – Jacksonville seeks an experienced Clinical Research Program Manager to oversee UF CARES’ HIV and non-HIV clinical research operations. You will lead research staff, ensure regulatory compliance, and coordinate budgets, sponsors, and milestones.

The role requires a master's or equivalent, and certification in shipping, CITI/NIH within 3 months. Strong supervision and process-improvement focus are essential.

Qualifications

• Masters degree in appropriate area of specialization; or a bachelors degree in appropriate areas of specialization and two years of experience.
• Obtain and maintain Shipping Dangerous goods certification and obtain and maintain CITI and NIH Certification within 3 months to maintain employment.
• Working knowledge of computers and computer software such as MS Word, Excel, and Outlook

Responsibilities

• Responsible for the overall management and coordination of clinical research activities within UF CARES.
• Manages and supervises Clinical Research Coordinators and other assigned research staff, including workload assignment, training, performance management, and staff development.
• Research Program Management and Operations – Plans, directs and coordinates the day-to-day operations of the UF CARES clinical research program.
• Personnel Management and Staff Development – Provides direct supervision and leadership to Clinical Research Coordinators and other assigned research personnel.
• Regulatory, Compliance and Quality Oversight – Oversees compliance with IRB, FDA, NIH, sponsor, University and other applicable research requirements.
• Financial and Administrative Management – Provides oversight of clinical research budgets and financial activities, including study budget review, sponsor billing, invoice reconciliation, research visit billing and appropriate use of grant and research funds.
• Study and Sponsor/PI Coordination – Serves as a primary operational liaison among the PI, research staff, sponsors, protocol teams, IRB, research pharmacy, departmental administration and other internal and external partners.
• Program Development and Process Improvement – Assists the PI and departmental leadership with growth and development of the clinical research program, including evaluation of new study opportunities, assessment of staffing and resource needs, development and implementation of procedures, and continuous improvement of research operations.
• Clinical Research Support – Maintains sufficient knowledge of active studies to provide guidance, coverage and direct study support when needed.

Skills

Regulatory awareness

Education

Master's degree or Bachelor's with 2 years experience

Tools

MS Word

Excel

Outlook

Job description

At the University of Florida, we are a people of purpose. We're committed to challenging convention and ourselves. We see things not as they are, but as they could be. And we strive for a greater impact: one measured in people helped...

Masters degree in appropriate area of specialization; or a bachelors degree in appropriate areas of specialization and two years of experience.

Job Description:

• Responsible for the overall management and coordination of clinical research activities within UF CARES. Provides operational leadership and oversight for HIV-related and non-HIV-related clinical research studies, including treatment, observational, and other research protocols. Works closely with the Principal Investigator, research staff, sponsors, regulatory agencies, departmental leadership, and University offices to ensure effective research operations and compliance with institutional, sponsor, federal, and regulatory requirements.
• Manages and supervises Clinical Research Coordinators and other assigned research staff, including workload assignment, training, performance management, and staff development. Oversees research program operations, regulatory compliance, quality assurance, study implementation, budgets, sponsor billing and financial activity. Provides guidance to investigators and staff regarding research policies, protocols, operational requirements, and appropriate use of program resources. May provide direct study coordination or coverage as operationally necessary.
• Research Program Management and Operations – Plans, directs and coordinates the day-to-day operations of the UF CARES clinical research program. Manages the portfolio of active and developing research studies and establishes priorities, workflows and processes to support program goals. Coordinates study start-up, implementation, ongoing operations and closeout. Works with the PI and research team to identify operational needs, resolve barriers and ensure appropriate allocation of staff and other resources.
• Personnel Management and Staff Development – Provides direct supervision and leadership to Clinical Research Coordinators and other assigned research personnel. Assigns and monitors workload; establishes expectations; evaluates performance; provides coaching and feedback; addresses performance or operational concerns; and supports recruitment, onboarding, training, cross-training and professional development. Promotes accountability, teamwork and consistent research practices across the program.
• Regulatory, Compliance and Quality Oversight – Oversees compliance with IRB, FDA, NIH, sponsor, University and other applicable research requirements. Ensures regulatory files, informed consent processes, protocol documentation, adverse event reporting, deviations and other required documentation are completed accurately and timely. Develops and monitors quality assurance processes and works with staff and investigators to address findings and implement corrective actions.
• Financial and Administrative Management – Provides oversight of clinical research budgets and financial activities, including study budget review, sponsor billing, invoice reconciliation, research visit billing and appropriate use of grant and research funds. Works collaboratively with departmental finance, contracts and grants, sponsors and investigators to monitor financial performance, identify discrepancies and support appropriate stewardship of research resources.
• Study and Sponsor/PI Coordination – Serves as a primary operational liaison among the PI, research staff, sponsors, protocol teams, IRB, research pharmacy, departmental administration and other internal and external partners. Advises the PI regarding research operations, study feasibility, resource requirements and implementation. Coordinates responses to sponsor and regulatory requests and supports timely resolution of study issues.
• Program Development and Process Improvement – Assists the PI and departmental leadership with growth and development of the clinical research program, including evaluation of new study opportunities, assessment of staffing and resource needs, development and implementation of procedures, and continuous improvement of research operations. Develops or recommends changes to workflows, policies and procedures as appropriate.
• Clinical Research Support – Maintains sufficient knowledge of active studies to provide guidance, coverage and direct study support when needed. May assist with participant recruitment, informed consent, data collection, specimen processing, study visits or other protocol activities based upon operational needs.

$82,000-$85,000

Required Qualifications:

• Masters degree in appropriate area of specialization; or a bachelors degree in appropriate areas of specialization and two years of experience.
• Obtain and maintain Shipping Dangerous goods certification and obtain and maintain CITI and NIH Certification within 3 months to maintain employment.
• Working knowledge of computers and computer software such as MS Word,Excel, and Outlook

Preferred:

• Clinical Research Certification, or acquired within 2-3 years of hire. Two years prior experience with clinical trials, including HIV/AIDS, Supervisory experience. Experience in NIH Studies specifically IMPACT, ACTG, PHACS and POPS Networks. Experience with UF IRB, Adverra IRB, and Western IRB. Experience with UFIRST and EHS.

Special Instructions to Applicants:

• This is a time-limited position. Time limited positions are based on circumstances, such as funding sources, which control the length of time for which the position is available.
• Background Check is Required.

University of Florida College of Medicine – Jacksonville: Visit this link to watch the video.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Work Visa sponsorship is not available for this position

Degrees earned from an education institution outside of the United States are required to be evaluated by a professional credentialing service provider approved by the National Association of Credential Evaluation Services (NACES), which can be found at http://www.naces.org/.

The University of Florida is a public institution and subject to all requirements under the Florida Sunshine and Public Records laws. If an accommodation due to a disability is needed to apply for this position, please call (352) 392-2HRS or the Florida Relay System at [phone] (TDD). Hiring is contingent upon eligibility to work in the US. Searches are conducted in accordance with Florida's Sunshine Law.