Manager, Clinical Research - Peds ID

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

Job summary

University of Florida College of Medicine - Jacksonville is seeking a Manager, Clinical Research - Peds ID to oversee the UF CARES clinical research program. You will lead operational activities, supervise coordinators, and ensure regulatory compliance across HIV-related and non-HIV studies.

The role focuses on study start-up, ongoing operations, and closeout while coordinating with investigators, sponsors, and regulatory bodies to optimize research performance.

Qualifications

• Masters degree in appropriate area of specialization; or a bachelors degree 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

• Oversees management and coordination of clinical research activities within UF CARES.
• Provides operational leadership for HIV-related and non-HIV research protocols.
• Supervises Clinical Research Coordinators and assigns workload, training, and performance.
• Directs study start-up, implementation, ongoing operations, and closeout processes.
• Ensures regulatory compliance and quality assurance across the program.
• Manages budgets, sponsor billing, and financial activity for studies.
• Coordinates with PI, sponsors, regulatory bodies, and university offices to ensure compliance.

Education

Master's degree in appropriate area

Bachelor's degree with 2 years experience

Tools

MS Word

Excel

Outlook

Job description

Job No:

541656

Work type:

Staff Full-Time

Location:

Jacksonville Campus

Categories:

Health Care Administration/Support

Department:

30090000 - JX-PEDIATRICS-JACKSONVILLE

Classification Title:

Manager, Clinical Research - Peds ID

Classification Minimum Requirements:

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.

Expected Salary:

$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.

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.

Health Assessment Required: yes