Clinical Research Coordinator, Varying Levels, Department Of Pediatrics

The Department of Pediatrics in the University of Virginia's (UVA) School of Medicine is seeking candidates for a Clinical Research Coordinator (CRC), licensed or non-licensed, at experience levels CRC 2 through CRC 4. The CRC will support clinical research efforts for the Pediatrics Department Chair as well as other divisions across the Department as needed. The individual will be responsible for assisting the Pediatrics Department Chair and other faculty in conducting National Institute of Health (NIH), industry sponsored clinical trials, and/or investigator-initiated trials. In this role, the CRC will work closely with the clinical team including faculty, advanced practice providers, and staff.

The focus of clinical research activities will vary based on the clinical trial portfolio and include patient facing activities, compliance management and clinical research administrative responsibilities. Clinical Research Coordinators levels 2 through 4 will have an understanding of the clinical research process and regulations, both federal and local, governing the conduct of clinical research. They will be able to manage multiple complex clinical trials simultaneously in accordance with current regulatory requirements and maintain study documentation in a manner that is audit ready.

For more information on the mission of the UVA Department of Pediatrics and the UVA Children's Hospital, please visit: https://med.virginia.edu/pediatrics/

Responsibilities of the successful candidate will vary based on the CRC level at the time of hire but include:

• Work closely with Principal Investigators and other study team members on all clinical research projects assigned.

• Become familiar with study start-up processes and requirements for: non-disclosure agreements, data use and material transfer agreements, clinical trial agreements, development of clinical trial budgets.

• Assist in preparation, maintenance or creation of study documents such as: study visit schedules, study drug diaries, monitoring or training logs, equipment records or study communications.

• Manage study recruitment and enrollment efforts including: screen and identify eligible patients, obtain and document informed consent and enrollment.

• Manage ongoing study conduct activities such as: schedule and coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments.

• Notify PI and/or supervisor of any potential issues with the study or subject status.

• Communicate effectively with study Sponsor(s).

• Liaise with other groups outside of the Department of Pediatrics to support clinical research activities that will enable us to run trials in an effective manner.

• Collect subject data, maintain appropriate logs, track participants and prepare study materials.

• Perform data entry into internal and external electronic databases.

• Collect process, prepare, store and ship laboratory specimens as necessary.

• Prepare and submit necessary documents for Institutional Review Boards (IRB), FDA, National Institutes of Health (NIH) or Data Safety Monitoring Board (DSMB) review; document and report protocol deviations.

• Able to work with minimal supervision.

• Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.

• Coordinate multiple clinical trials or research projects simultaneously or manage large individual clinical trials that may be multicenter and complex in nature.

• Manage all aspects of ongoing clinical trial conduct from enrollment to off-study visits, data management, safety reporting, and compliance oversight.

• Reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third-party payer.

• Orient and/or provide basic training to new study team members.

• Demonstrate a high level of proficiency with the various electronic platforms utilized in clinical research such as IRB Pro, Protocol Builder, OnCore, iMedidata, Inform, Openclinica, Epic, and other data management platforms.

• Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning.

• In addition to the above job responsibilities, other duties may be assigned.

Minimum Qualifications:

• 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.

• 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: 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.

• 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 (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.

Physical Demands:

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

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

This position will remain open until filled. 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. This position will not sponsor applicants for work visas.

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

To Apply:

Please apply through Workday, and search for R0053885.

Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'

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.

For questions about the application process, please contact Yelena Markazyan, Academic Recruiter at ym3mm@virginia.edu

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, including 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 (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.