Clinical Research Coordinator 2-4/Regulatory Specialist

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.

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.
  

Career Development:

This role is suited for experienced clinical research professionals seeking to advance their careers by taking on more complex duties and greater responsibility within clinical research. It provides opportunities for professional growth and the potential to contribute significantly to the success of clinical trials and the advancement of medical knowledge.

For questions about the position, please contact Nicole Sprouse, at njb6m@uvahealth.org .

MINIMUM REQUIREMENTS:

Clinical Research Coordinator 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.

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

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

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

Preferred Experience:
• Regulatory experience is a plus.
• Extensive experience with managing multiple clinical research studies simultaneously
• Proficiency in computer/automated systems for data purposes
• Effective use of Microsoft Office (Word, Excel, PowerPoint, and Outlook) and Microsoft OneDrive

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 is an exempt level, benefited position. For more information on the benefits at UVA, visit hr.virginia.edu/benefits. This position is a restricted position and is dependent upon project need, availability of funding and performance.

This position will not sponsor applicants for work visas.

The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen is required for this position prior to employment.

To Apply:

Please apply through the UVA job board , and search for R0064772.

Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs' and search for R0064772.

Complete an application online with the following documents:

• CV
  
• Cover letter
  

Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration.

References will be completed via UVA's standardized process Skill Survey. A total of five references will be requested via Skill Survey during the final phase of the interview process.

For questions about the application process, please contact Michelle Johnson , Recruiter.

For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/ .

The University of Virginia, i ncluding the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician's Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex, pregnancy, sexual orientation, veteran or military status, and family medical or genetic information.