Clinical Research Coordinator 4, Post-Award Supervisor

Clinical Research Coordinator- 4, plan, organize, lead, and perform comprehensive and advanced level clinical research duties for multiple and/or complex clinical trials. A CRC 4 has the ability to directly impact the overall efficiency, productivity and success of each clinical trial they coordinate. The CRC in this role is able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within their respective Department or Division to meet the needs of a given study. A CRC in this role may manage or support a research team of CRCs.

Job Description

• This role will be evenly divided between primary study coordination and post-award activities for the orthopedic department. This role will work with the pre-award supervisor to ensure all aspects of the clinical trial lifecycle are supervised.
• Manage multiple Principal Investigator relationships with internal and external research stakeholders.
• Provide guidance and assistance to Principle Investigators for grant submissions and/or potential industry funded clinical trials, budget development & negotiation, study feasibility, and research compliance oversight to ensure full compliance with local, state and federal policies and procedures.
• This role will have an emphasis on managing the active study budgets, tracking sponsor invoices and payments, and all post approval financial aspects
• Serve as the primary liaison with the Sponsor for assigned studies.
• Assist Principal Investigator in developing clinical trial protocols and submit the required documentation to the Institutional Review Board, the University, federal regulators n industry or government sponsor.
• Coordinate and manage all aspects of clinical trial conduct for multiple ongoing clinical trials of any level of complexity.
• Prepare and submit all types of clinical research documentation to the IRB of record (central or local) for review and approval.
• Participate in planning and analysis of research portfolios, in conjunction with department management, leadership and Principal Investigators.
• Oversee the financial management of multiple clinical research projects, including budget development, billing reconciliation, and quarterly review of all Principal Investigator accounts.
• Oversee the CRCs to ensure enrollment progress and milestone completion is timely.
• Work with the Clinical Trials leadership to manage a team of Clinical Research Coordinators and/or laboratory or research support staff, with responsibilities that include hiring, scheduling, workload management, compensation, rewards, professional development, and performance management.
• Coordinate clinical research education, training and/or orientation for new Faculty, Fellows, Residents or medical students.

• Provide guidance and training to research coordinators and departmental staff on post-award financial management, sponsor invoicing, and regulatory requirements.

• Develop administrative and financial recommendations for department management and Principal Investigators for research portfolio review.

• Oversee Clockify for clinical research coordinators and improve time each week based upon departmental guidelines.

• Compile data and documents during internal and external audits and is ultimately responsible for quality of submissions.
• Participate in at least 1 research-related working group at the institutional level, or lead a process improvement initiative at a department or division level.
• Conduct research data analysis and literature searches. Co-author scientific papers, publications or presentations

• If unfunded (or under-funded), identify the funds needed and assist investigators in submitting proposals to the research committee for approval. Once approved and funding source is identified, work with research administrators to load info in Clockify.

• Identify opportunities to streamline study start-up processes and reduce activation timelines.

• Track key start-up metrics including time to budget finalization and study activation
• In addition to the above job responsibilities, other duties may be assigned.

MINIMUM REQUIREMENTS

CRC 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.

*Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.

CRC 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: 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.

*Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.

PREFERRED QUALIFICATIONS

• Master's degree in Public Health (MPH), Healthcare Administration (MHA), Business Administration (MBA), or related field.
• Experience with Clinical Trial Management Systems (CTMS) such as OnCore.
• Experience working with contract research organizations (CROs) and industry sponsors.
• Clinical trial budget development and negotiation
• Study start-up coordination and timeline management
• Financial feasibility analysis for clinical trials
• Knowledge of clinical trial billing compliance and coverage analysis
• Stakeholder communication and negotiation skills
• Project management and organizational skills
• Attention to detail and regulatory awareness

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.

This position operates within a collaborative academic medical center research environment supporting clinical and translational research programs. The role requires frequent interaction with investigators, research coordinators, sponsors, contract offices, and compliance teams.

Salary will be commensurate with education and experience.

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 is eligible for a hybrid schedule, in accordance with UVA's remote work guidelines.

About UVA and the Community

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

Additional Requirements

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

This position will not consider candidates who require immigration sponsorship now or in the future.

How to Apply

Please apply online, by searching for requisition number R0083385. 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: Search and apply for jobs on the UVA Internal Careers website.

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 Jeremy Brofft, Senior Academic Recruiter at xmf9ad@virginia.edu.

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