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University of Virginia

Clinical Research Operations Lead, Pediatrics

University of Virginia, Charlottesville, Virginia, United States, 22904

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Clinical Research Operations Lead, Pediatrics

Join to apply for the Clinical Research Operations Lead, Pediatrics role at University of Virginia. Overview

The Department of Pediatrics at the University of Virginia (UVA) School of Medicine seeks a full-time Clinical Research Operations Lead to lead its dynamic research team. The Department’s research mission spans a comprehensive clinical research portfolio across 20 divisions, supported by 20 clinical research coordinators conducting 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. This role requires a strong leader who can manage and direct efforts supporting a diverse portfolio of trials. The department prides itself on its research activity and funding from federal and other sources, including a 340B program and foundations, with interfaces to faculty and staff across grants." 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 needs, forecast staffing, and identify funding or transitional support to bridge gaps until divisional CRCs are onboarded. Assess trial requirements, prepare budget forecasts, and monitor expenditures to ensure successful conduct throughout the trial lifecycle. Participate in development of clinical research policies and procedures at department level. Determine and manage departmental resources needed to execute clinical research, including budgets, space, staffing, and access to technology and tools. Identify operational challenges and support process improvements across departmental research projects. Develop and maintain backup coverage plans for CRCs to ensure continuity during planned and unplanned absences. Coordinate with CRCs across divisions to support unfunded or soon-to-be-funded projects. Oversee and manage all clinical research staff including hiring, training, scheduling, workload, compensation, professional development, and performance management. Prepare reports highlighting division or department research activities, accomplishments, and improvement areas. Engage in clinical research business development and collaborations 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 and Operations

Develop and support operational components for new protocols, including protocol submission, study enrollment, sample processing, and regulatory activities. Conduct clinical research activities within licensure and UVA guidelines, including physical exams, vital signs, clinical assessments/procedures, medication administration, and adverse event management. Implement protocols and perform ongoing quality reviews; assist Principal Investigators in protocol development and required documentation submissions to institutional and federal bodies and sponsors. Assist with grant proposal development and clinical trial protocol writing. Oversee financial management of clinical research budgets, including budget development and billing reconciliation, and negotiate trial budgets and contracts as appropriate. 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 with progressive responsibility (finances, portfolio oversight, staff management, and performance management). Master’s degree may substitute for one year of experience. Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) required within one year of hire. Clinical Research Coordinator 4, Non-Licensed Education: Bachelor’s degree or equivalent. Experience: At least seven years of clinical research experience with progressive responsibility. Master’s degree may substitute for one year of experience. Licensure: CCRC and/or CCRP required within one year of hire. Clinical Research Coordinator 4, Licensed Education: Bachelor’s degree or equivalent; Nursing Diploma may substitute for degree for licensed RN. Experience: At least seven years of clinical research experience with progressive responsibility. Master’s degree may substitute for one year of experience. Licensure: CCRC and/or CCRP required within one year of hire. Licensure in a clinical profession (e.g., RN, Athletic Trainer, Pharmacology, Medical Technology, Physical Therapy, or Respiratory Therapy). Physical Demands

This is primarily a sedentary job involving extensive use of desktop computers. The role may require travel to attend meetings and programs as needed. Position Type & Work Location

This is an exempt-level, benefited position. This is a restricted position dependent on funding and funding availability. The position is based in Charlottesville, VA, and must be performed on-site. About UVA And The Community

To learn more about UVA and the Charlottesville area, visit UVA Life and Embark CVA. Application Review

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

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 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 conducted 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, contact Karon Harrington, fak3ph@virginia.edu. For questions about the position, contact Alex Torres, avt6g@virginia.edu. The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Read UVA’s commitment to non-discrimination and equal opportunity employment

here .

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