Regulatory Clinical Research Coordinator (CRC), Licensed or Non-Licensed, varying levels

The Rector & Visitors of the University of Virginia; Charlottesville (VA); On-site; USD 60,000 - 80,000; Full time

Job summary

The Rector & Visitors of the University of Virginia in Charlottesville is hiring Clinical Research Coordinators (CRC) for various levels in their Cardiovascular Medicine department. Candidates will oversee clinical trials, ensuring compliance with regulatory standards while working closely with leading researchers. Positions available for both licensed and non-licensed applicants. The role requires a Bachelor's Degree and relevant clinical research experience, and it offers a full-time, on-site opportunity in a collaborative environment.

Qualifications

• At least one year of clinical research experience.
• Experience in a healthcare setting and knowledge of medical terminology preferred.
• Must be licensed to practice in a clinical profession.

Responsibilities

• Oversee the entire lifecycle of clinical trials from initiation to close-out.
• Manages regulatory activities for all stages of clinical trials.
• Prepares and submits regulatory documents to sponsors and IRBs.

Skills

Regulatory Acumen

Technical Proficiency

Communication Skills

Leadership

Education

Bachelor's Degree or equivalent

Job description

The Division of Cardiovascular Medicine (Interventional Cardiology) at the University of Virginia's (UVA) School of Medicine, is currently seeking applicants for Clinical Research Coordinators (CRC), licensed or non‑licensed positions, at various skill and experience levels to join a dynamic growing team of clinical research professionals.

This position is open to applicants who meet the requirements of Clinical Research Coordinator 2, 3, and 4.

The CRC will work closely with physicians, research staff, sponsors, IRB, and regulatory department staff, coordinating all regulatory aspects of clinical research from study start‑up through archiving of study records.

The Research Regulatory Coordinator leads, coordinates, and oversees regulatory processes across multiple studies of different therapeutic CV disease areas and phases, in accordance with appropriate regulations, institutional policies, standard operating procedures, and study‑specific protocols.

Studies may be large, nationwide, or moderately complex involving multiple sites and/or assessments and interventions.

This position works closely with world‑renowned Principal Investigators and other research team members during the life cycle of the trial, maintaining quality management of the trial portfolio.

Regulatory CRCs play a critical role in the success of research, and will have the opportunity to work on clinical trials involving innovative devices treating structural heart disease, heart failure, high blood pressure, and coronary artery disease, as well as studies of new pharmaceuticals for cardiovascular conditions including high cholesterol, cardiac inflammatory processes, and hypertrophic cardiomyopathy.

Responsibilities

• Oversee the entire lifecycle of clinical trials from initiation to close‑out.
• Manages regulatory activities for all stages of clinical trials for the assigned department.
• Prepares and submits regulatory documents to sponsors and IRBs, ensuring documents are up‑to‑date.
• Ensures adherence to study protocols, GCP, and regulatory requirements.
• Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials and provides guidance and training to research staff.
• Facilitates the submission of regulatory documents to IRBs and other regulatory entities.
• Prepares and maintains all study‑related documentation, including informed consent documents, delegation of authority logs, and training records.
• Facilitates the use of eFlorence, ONCORE, CRConnect/2, and other UVA required programming.
• Completes industry registrations and study feasibility questionnaires including receipt, tracking, and correspondence with sponsor/CRO/ARO.
• Monitors approval status of open studies by completing timely reviews and completing IRB renewals prior to expiration, communicating with sponsor on renewals.
• Maintains master files of all regulatory‑related documents — electronically and in hard copy.
• Assists in submission of Investigational New Drug (IND) applications including amendments and reporting.
• Coordinates schedules of on‑site visits, including introductions, tours, EMR access, sponsor/CRO/ARO requests, and monitoring visits.

Team Leadership and Training

• Supervises and mentors junior CRCs and support staff in regulatory compliance and IRB guidelines.
• Provides training on study protocols, regulatory requirements, and best practices.
• Fosters a collaborative and efficient team environment.

Liaison Activities

• Acts as a key contact between the research team, study sponsors, regulatory bodies, and other stakeholders.
• Co‑ordinates study meetings, including site initiation visits, monitoring visits, and audits.
• Communicates effectively with Principal Investigators (PIs) and keeps them informed of study progress and any issues that arise.

Regulatory Compliance and Quality Assurance

• Conducts routine quality checks to ensure compliance with regulatory standards.
• Assists in preparation for and conducts internal and external audits.
• Implements corrective action plans as necessary to address compliance issues.

Knowledge and Skills

• Regulatory Acumen: In‑depth knowledge of FDA regulations, ICH GCP guidelines, and state‑specific regulatory requirements.
• Technical Proficiency: Familiarity with electronic data capture systems, clinical trial management systems (CTMS), and other relevant software.
• Communication Skills: Excellent written and verbal communication skills for effective interaction with study team members, and external partners.
• Leadership: Strong leadership abilities to guide, motivate, and manage compliance in junior CRCs.

Minimum Requirements – Non‑Licensed

CRC 2 Non‑Licensed

Education: Bachelor's Degree Required or equivalent combination of experience, education, and/or certifications.

Experience: At least one year of clinical research experience. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.

Licensure: None.

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

CRC 3 Non‑Licensed

Education: Bachelor's Degree Required or equivalent combination of experience, education, and/or certifications.

Experience: Minimum of 3 years of clinical research experience required. Master's degree may substitute for 1 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 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.

Minimum Requirements – Licensed

Licensure Requirement: Must be licensed to practice in a clinical profession such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy, Registered Respiratory Therapy.

CRC 2 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 one year of clinical research experience.

CRC 3 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: Minimum of 3 years of clinical research experience required. Master's or advanced degree may substitute for 1 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.

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

Physical Demands

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

Salary and Benefits

Salary will be commensurate with education and experience.

This is an exempt‑level, benefited position.

Location

This position is based in Charlottesville, VA, and must be performed fully on‑site.

Equal Opportunity Employer

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.