Regulatory Clinical Research Coordinator, CRC 1-CRC 4, Cardiology (Interventional Cardiology)
Job ID: R0042394 | Clinical Research | Full Time | Charlottesville, VA
The Division of Cardiovascular Medicine (Interventional Cardiology) at the University of Virginia's (UVA) School of Medicine is currently seeking applicants to join their team as a Regulatory Coordinator, CRC, at various skill and experience levels. This candidate will join a dynamic, growing team of clinical research professionals. This position is open to applicants who meet the requirements of Clinical Research Coordinator 1, 2, 3, or 4 in a licensed or non-licensed role. The CRC will work closely with physicians, CRC research staff, IRB, sponsors, and regulatory agencies on all regulatory aspects of clinical trial protocols. The successful candidate will be responsible for coordinating all regulatory aspects of clinical trial protocols, from study start-up through archiving of study records.

The Regulatory Coordinator, working closely with world-renowned principal investigators in their field and other team CRC members, will be responsible for independently submitting and processing UVA Cardiology/Cardiovascular research protocols for regulatory review by IRB-HSR, Central IRBs, and FDA. The incumbent serves as the contact with relevant regulatory authorities and sponsor representatives.

The incumbent is responsible for multiple clinical trial protocols with duties to include:
  • IRB protocol and Informed Consent submissions for study start-up and protocol amendments as required.
  • Preparing Central Institutional Review Board (CIRB) expedited submissions to the IRB.
  • Processing adverse events, amendments/revisions, personnel changes, study continuations, Investigational New Drug (IND) safety reports, and investigator brochures.
  • Maintaining regulatory compliance using IRB PRO, OnCore, and CRConnect.
  • Administering physical and electronic trial files.
  • Drafting, collecting, and maintaining essential regulatory documents, to include 1572, delegation of authority records.
  • Working with clinical trial sponsors to maintain protocol compliance.
  • Submitting Informed Consent Form (ICF) language to appropriate committees (e.g., HIRE) and sponsors/IRB for approvals.
  • Responding to Data and Safety Monitoring Committee (DSMC) reports.
  • Preparing and transmitting responses generated from internal Post Approval Monitoring (PAM) audits related to regulatory items.
  • Adhering to deadlines, editing material as requested by governing boards, and following progress of approval steps for trial protocols.
  • Working on the preparation, completion, and organization of regulatory documentation for each clinical trial as needed and as primary assignment allows.
  • Notifying principal investigator and sponsors of study regulatory status changes.
  • Conveying accurate and comprehensive study information to principal investigator, supervisory personnel, study sponsor, members of the interdisciplinary team involved in the studies, and peers.
  • Serving as the liaison with the sponsor for all assigned studies.
  • Preparing study status reports as required annually for all assigned studies.
  • Working with department management on study status to ensure contract updates and UVA billing coverage analyses are current per protocols and for subject research billing.
  • Keeping current in federal, state, and local regulations governing clinical trial activities and performing all activities in compliance with these regulations.
  • Attending team meetings to report regulatory updates as needed.
  • In addition to the above responsibilities, other duties may be assigned.

The Division of Cardiovascular Medicine continues to be a leader in national and international pivotal clinical research and our CRCs play a critical role in the success of research. The CRC will have the opportunity to work on clinical trials that include innovative devices treating structural heart disease, heart failure, high blood pressure, coronary artery disease, and pulmonary hypertension. In addition, our clinical research professionals are involved with studies of new pharmaceuticals treating a wide range of cardiovascular disease, such as high cholesterol, pulmonary hypertension, and coronary disease.

Research reference information:

Innovating proctoring with live/recorded surgical cases, spanning across departments:
https://www.uvaphysicianresource.com/uva-structural-heart-disease-team-performs-live-cases-at-the-2021-international-tvt-conference/

New and innovative treatments for heart failure:
https://www.nbc29.com/2021/01/15/uva-doctors-working-towards-therapy-patients-with-form-heart-failure/

Spanning across all areas of healthcare, including immunology and how it relates to cardiovascular disease:
https://giving.uvahealth.com/article/new-outlook-immunology-uva
NIH Grants UVA Researchers $2.7 Million

MINIMUM REQUIREMENTS:

Clinical Research Coordinator 1, Non-Licensed
  • Education: Bachelor's degree required or equivalent combination of experience, education, and/or certifications.
  • Experience: None. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.

Clinical Research Coordinator 1, 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: None.
  • 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 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 dlinical 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.

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. 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.

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 will remain open until filled. This is a full-time, 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 is located in Charlottesville, VA.

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

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



COVID Vaccination Requirement and Guidelines

 

Please visit the UVA COVID-19 Job Requirements and Guidelines webpage prior to applying for current information regarding vaccination requirements and guidelines for employment at UVA.

 

 

 


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