Clinical Research Operations Lead, Pediatrics

The Department of Pediatrics at the University of Virginia (UVA) School of Medicine seeks a candidate for a full-time Clinical Research Operations Lead to lead its dynamic research team. The Department's research mission is comprehensive and includes an expansive clinical research portfolio that spans its 20 divisions. The clinical research efforts are made possible by the Department's 20 clinical research coordinators that facilitate over 115 active protocols. The Clinical Research Operations Lead will collaborate closely with the Clinical Research Team Lead(s), who oversee specific divisions within the Department of Pediatrics.

Outside of clinical research, the Department of Pediatrics at the University of Virginia is proud to be ranked #36 (and rising!) in the Blue Ridge Institute for Medical Research. In addition to federal funding, the Department has a diverse range of research funding that includes a 340B program, grants from foundations, state governments, foreign entities and other colleges and universities. This role will interface closely with the faculty and staff that are part of these grants. This position requires a strong leader who can effectively manage and direct efforts supporting a diverse portfolio of trials.

Responsibilities

• Conduct strategic planning and analysis of department research portfolios, in conjunction with department management and Principal Investigators.
• Develop and support operational plans for new research proposals. Work with faculty to assess trial, forecast staffing needs and identify funding or transitional support to bridge gaps until divisional CRCs are onboarded.
• Assess specific requirements of trials, prepare budget forecasts, and monitor expenditures to ensure successful conduct in the lifecycle of trial.
• Participate in development of clinical research policies and procedures at department level.
• Determine and manage departmental resources needed to successfully execute clinical research including: department research budgets, clinical research space, staffing availability, and access to appropriate technology and tools to conduct research.
• Identify operational challenges and support the development and implementation of process improvements across all departmental research projects.
• Develop and maintain comprehensive backup coverage plans for CRCs to ensure continuity of study operations during both planned (e.g., PTO, FMLA) and unplanned (e.g., sick leave) absences.
• Exercise discretion and authority to coordinate with CRCs across divisions to support faculty with unfunded or soon-to-be-funded projects.
• Oversee and manage all clinical research staff including hiring, training, staff scheduling, workload assignments, compensation management, professional development and performance management.
• Work with department research leadership and Team Lead(s) to prepare reports highlighting division or department research activities, accomplishments and areas for improvement.
• Work within the department, School of Medicine, broader University, and outside the University in the pursuit of clinical research business development and/or collaborations with other research institutions promoting the University's resource capabilities.
• Provide day-to-day leadership and oversight of clinical research initiatives and programs within Pediatrics, including the student internship program and community-engaged research efforts.

Study Conduct Level

• Develop and support all operational components for new protocols, including but not limited to protocol submission, study enrollment, sample processing, regulatory, etc.
• Conduct clinical research activities within the scope of licensure and UVA guidelines, such as physical exams, vital sign assessments, clinical assessments/procedures, medication administration, and symptom/adverse event management.
• Implement protocols and conduct ongoing quality reviews of clinical research: Assist Principal Investigators in developing clinical trial protocols and submit required documentation to the Institutional Review Board, University offices, federal regulators, and industry or government sponsors.
• Assist with the development and submission of grant proposals and with writing clinical trial protocols.
• Oversee the financial management of clinical research budgets, including budget development and billing reconciliation. Facilitate negotiation of trial budgets and contracts ensuring that all trial-related expenses are accurately recorded and justified.

Minimum Qualifications

Manager, Clinical Research
Education: Bachelor's degree required. Master's or other advanced degree preferred.
Experience: At least 10 years of clinical research experience demonstrating progressive levels of responsibility including but not limited to: management of research finances, clinical trial portfolio oversight, hiring and training research staff, and performance management. Master's or other advanced degree may substitute for one year of clinical research experience.
Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.

Clinical Research Coordinator 4, Non-Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master's or other advanced degree may substitute for one year of clinical research experience.
Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.

Clinical Research Coordinator 4, Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse.
Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master's or other advanced degree may substitute for one year of clinical research experience.
Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. Licensed to Practice in Clinical Profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy or Registered Respiratory Therapy.

Physical Demands
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs..

Position Type & Work Location

• This is an exempt-level, benefited position. Learn more about UVA benefits.
• This is a restricted position, which is dependent on funding and is contingent upon funding availability.
• This position is based in Charlottesville, VA, and must be performed fully on-site.

About UVA and the Community
To learn more about UVA and in the Charlottesville area, visit UVA Life and Embark CVA.

Application review will begin after September 26, 2025. Preference will be given to applications received by this date.

Additional Requirements
Background checks, pre-employment health screenings, and drug screenings will be conducted on all new hires prior to employment.

How to Apply
Use standard language only. Do not edit. Recruiters will enter the requisition number prior to posting.
Please apply online, by searching for requisition number R0076062. Complete an application with the following documents:

• Resume
• Cover Letter

Upload all materials into the resume submission field. You can submit multiple documents into this one field or combine them into one PDF. Applications without all required documents will not receive full consideration.

Internal applicants: Apply through your Workday profile by searching "Find Jobs."

Reference Check Process
Reference checks will be completed by UVA's third-party partner, SkillSurvey, during the final phase of the interview. Five references will be requested, with at least three responses required.

Contact
For questions about the application process, please contact Karon Harrington, fak3ph@virginia.edu.
For questions about the position, please contact Alex Torres, avt6g@virginia.edu.

Experience:

• At least 7-10 years of clinical research experience demonstrating progressive levels of responsibility including but not limited to: research experience, management of research finances, clinical trial portfolio oversight, hiring and training research staff, and performance management. Master's or other advanced degree may substitute for one year of clinical research experience.

Required Education and Credentials:

• Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
• Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required. Related Master's degree with significant work experience may substitute, with certification required within one year of eligibility.
• Certified Clinical Research Associate (CCRA) is strongly preferred.

Physical Demands:

• This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.

The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Click here to read more about UVA's commitment to non-discrimination and equal opportunity employment.