Clinical Research Operations Lead, Pediatrics

University of Virginia • VA

120d

About The Position

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.

Requirements

• Bachelor's degree required. Master’s or other advanced degree preferred.
• 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.
• Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.

Nice To Haves

• Certified Clinical Research Associate (CCRA) is strongly preferred.

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.
• 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.

Benefits

• This is an exempt-level, benefited position.
• Background checks, pre-employment health screenings, and drug screenings will be conducted on all new hires prior to employment.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Bachelor's degree