Manager, Clinical Research - Peds ID

UF ECE Ambassadors; Jacksonville (FL); On-site; USD 82,000 - 85,000; Full time

Job summary

UF CARES in Jacksonville, FL seeks a Manager for Clinical Research - Peds ID to lead day-to-day operations of HIV-related and non-HIV-related studies. You will oversee coordinators, align budgets, and ensure compliance with IRB and sponsor requirements.

The role requires a Masters or a Bachelor's plus two years of experience, with certifications in shipping, CITI, and NIH within three months. Strong leadership and communication are essential.

Qualifications

• Masters degree or Bachelors with two years of experience in a related field.
• Shipping dangerous goods certification required within 3 months.
• CITI and NIH certifications required within 3 months.
• Proficient in MS Word, Excel and Outlook.

Responsibilities

• Oversee overall management and coordination of clinical research programs.
• Supervise Clinical Research Coordinators and staff, including workload and performance.
• Ensure regulatory compliance, study budgets and sponsor billing.
• Provide guidance on policies, protocols and resource use.
• Coordinate study start-up, execution, and closeout with PI and team.

Skills

Staff supervision

Operations management

Regulatory compliance knowledge

Communication skills

Education

Masters degree or Bachelors + 2 years experience

Shipping Dangerous Goods Certification

CITI Certification

NIH Certification

Tools

MS Word

Excel

Outlook

Job description

Classification Minimum Requirements

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

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.

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.