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

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. The successful candidate will be responsible for 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 (SOPs), and study specific protocols/plans and processes independently. Studies may be large, nationwide, or moderately complex involving multiple sites and/or assessments/interventions. This position works closely with the world-renowned Principal Investigators in their field, and other research team members during the life cycle of the trial. The incumbent is responsible for maintaining quality management of the trial portfolio. The Division of Cardiovascular Medicine continues to be a leader in national and international clinical research and our Regulatory CRCs play a critical role in the success of research. The Regulatory CRC will have the opportunity to work on clinical trials that include innovative devices treating structural heart disease, heart failure, high blood pressure, and coronary artery disease. In addition, our Clinical research professionals are involved with studies of new pharmaceuticals treating a wide range of cardiovascular disease such as high cholesterol, cardiac inflammatory processes and hypertrophic cardiomyopathy.

Responsibilities:

Study Coordination and Management :

Oversee the entire lifecycle of clinical trials from initiation to close-out. Manages regulatory activities for all stages of clinical trials for assigned department. Prepares and submits regulatory documents to Sponsor and IRBs. Works with clinical research team to ensure submission documents are up-to-date Ensure adherence to study protocols, GCP, and regulatory requirements. Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials. Provides guidance and training to research staff to ensure compliance with rules and regulations associated with clinical research studies Facilitate the submission of regulatory documents to Institutional Review Boards (IRBs) and other regulatory entities. Prepare and maintain all study-related documentation, including informed consent documents, delegation of authority logs, training records, etc. 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 Monitor approval status of open studies by completing timely reviews and completing IRB renewals prior to expiration and communicating with sponsor on renewals. Maintain master files of all regulatory-related documents - electronically and in hard copy Assist in submission of Investigational New Drug (IND) applications including amendments and reporting Coordinate schedules of on-site visits including introductions, tours, EMR access and Sponsor/CRO/ARO requests, and monitoring visits

Team Leadership and Training :

Supervise and mentor junior CRCs and support staff in regulatory compliance and IRB guidelines. Provide training on study protocols, regulatory requirements, and best practices. Foster a collaborative and efficient team environment.

Liaison Activities :

Act as a key contact between the research team, study sponsors, regulatory bodies, and other stakeholders. Coordinate study meetings, including site initiation visits, monitoring visits, and audits. Communicate effectively with Principal Investigators (PIs) and ensure they are kept informed of study progress and any issues that arise.

Regulatory Compliance and Quality Assurance :

Conduct routine quality checks to ensure compliance with regulatory standards. Assist in the preparation for and conduct of internal and external audits. Implement 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. 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 preferred at the time of hire and is required within one year. 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 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:

A 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 does occasionally require traveling some distance to attend meetings, and programs. Learn more about the field of Clinical Research at UVA, School of Medicine! 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 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 . Additional Requirements Background checks, pre-employment health screenings, and drug screening s 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

R0083370

. 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 .