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

UVA Health•Charlottesville, VA

46d•Onsite

About The Position

The Division of Cardiovascular Medicine (Interventional Cardiology) at the University of Virginia’s (UVA) School of Medicine is seeking applicants for Clinical Research Coordinators (CRC), Licensed or Non-Licensed positions, at various skill and experience levels. 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.

Requirements

In-depth knowledge of FDA regulations, ICH GCP guidelines, and state-specific regulatory requirements.
Familiarity with electronic data capture systems, clinical trial management systems (CTMS), and other relevant software.
Excellent written and verbal communication skills for effective interaction with study team members, and external partners.
Strong leadership abilities to guide, motivate, and manage compliance in junior CRCs.
Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
At least one year of clinical research experience.
Some experience in a healthcare setting and/or knowledge of medical terminology is preferred (for CRC 2 non-licensed).
Minimum of 3 years of clinical research experience required (for CRC 3 non-licensed).
Master’s degree may substitute for 1 year of clinical research experience (for CRC 3 non-licensed).
At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work (for CRC 4 non-licensed).
Master’s or other advanced degree may substitute for one year of clinical research experience (for CRC 4 non-licensed).
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 (for licensed positions).
Nursing Diploma may substitute for Degree for Licensed Registered Nurse (for licensed positions).
At least one year of clinical research experience (for CRC 2 licensed).
A minimum of 3 years of clinical research experience required (for CRC 3 licensed).
Master’s or advanced degree may substitute for 1 year of clinical research experience (for CRC 3 licensed).
At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work (for CRC 4 licensed).
Master’s or other advanced degree may substitute for one year of clinical research experience (for CRC 4 licensed).
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.

Nice To Haves

Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year (for CRC 3 non-licensed).
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire (for CRC 4 non-licensed).
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire (for CRC 3 licensed).
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire (for CRC 4 licensed).

Responsibilities

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
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.
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.
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.