Clinical Research Coordinator (CRC 1), Ehlers-Danlos Program , Department of Pediatrics

UVA Health

5h•Onsite

About The Position

The Department of Pediatrics in the University of Virginia’s (UVA) School of Medicine and the Ehlers-Danlos Program at UVA Health is seeking a Clinical Research Coordinator (CRC) Level 1 (licensed or non-licensed). The CRC will support clinical research efforts in divisions across the Department and within the program, as needed. The individual will be responsible for assisting Principal Investigators 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. Job/Role responsibilities will include patient facing activities, compliance management and clinical research administrative responsibilities. A CRC 1 (licensed and non-licensed) is a role that provides an excellent avenue for an individual to begin a rewarding career in clinical research. In this role, one has the opportunity to receive on-the-job training to learn how to perform some of the basic tasks carried out by a clinical research coordinator. There is also a heavy focus on education to provide a strong foundational level of knowledge in clinical research as a whole. This is a role that involves intense cumulative learning to lay the groundwork for a successful career as a clinical research coordinator. A CRC 1 will work under direct supervision of a Principal Investigator and/or an experienced CRC and will be assigned clinical research duties as deemed appropriate by a designated supervisor. 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/ For more information on the mission of the Ehlers-Danlos Program at UVA Health, please visit: Connecting the Pieces: UVA Health’s Ehlers-Danlos Program The successful candidate will be expected to: Work closely with an experienced CRC and/or Principal Investigator to learn the full scope of clinical research duties. With the mentorship of a CRC and/or PI, learn how to read and follow a clinical trial protocol as it is written. Demonstrate a clear understanding of the importance of patient safety in clinical research and identify the components of a clinical trial protocol that are employed to protect patient safety. Engage in the following study conduct activities: screen and identify eligible patients, obtain and document informed consent, enroll subjects in a study. Manage ongoing study conduct activities such as: coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments. Collect and enter study data in a timely fashion, maintain corresponding documentation. Collect, process, store and ship study specimens as needed. Assist in preparation and maintenance of existing study documentation such as: study visit schedules, study drug diaries, monitoring and or training logs, equipment records or study communications. Prepare and submit basic regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, and minor protocol modifications. Become familiar with the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic. 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. To be promoted, a CRC 1 must demonstrate a basic understanding of clinical research processes and regulations (federal and local) that govern the conduct of clinical research.

Requirements

CRC 1, Non-Licensed Education: Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
CRC 1, Non-Licensed Experience: None. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
CRC 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.
CRC 1, Licensed Experience: None.
CRC 1, Licensed 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

Nice To Haves

Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.

Responsibilities

Work closely with an experienced CRC and/or Principal Investigator to learn the full scope of clinical research duties.
With the mentorship of a CRC and/or PI, learn how to read and follow a clinical trial protocol as it is written.
Demonstrate a clear understanding of the importance of patient safety in clinical research and identify the components of a clinical trial protocol that are employed to protect patient safety.
Engage in the following study conduct activities: screen and identify eligible patients, obtain and document informed consent, enroll subjects in a study.
Manage ongoing study conduct activities such as: coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments.
Collect and enter study data in a timely fashion, maintain corresponding documentation.
Collect, process, store and ship study specimens as needed.
Assist in preparation and maintenance of existing study documentation such as: study visit schedules, study drug diaries, monitoring and or training logs, equipment records or study communications.
Prepare and submit basic regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, and minor protocol modifications.
Become familiar with the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic.
Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning.