Non-licensed Clinical Research Coordinator (varying levels), Gastroenterology and Hepatology

UVA Health

70d•Onsite

About The Position

The Division of Gastroenterology and Hepatology at the University of Virginia’s School of Medicine is currently seeking applicants for non-licensed Clinical Research Coordinators (CRC), at various skill and experience levels to join a dynamic and growing team of clinical research professionals. This position is open to applicants who meet the requirements of Clinical Research Coordinator 2-3. This position will work closely with world-renowned Principal Investigators, and other Research Team members during the performance of clinical trials. The incumbent is responsible for maintaining quality management of the trial portfolio and there is often close collaboration with other CRCs on the Research Team. The Division of Gastroenterology and Hepatology continues to be a leader in national and international pivotal clinical research and our CRCs play a critical role in the success of the Research Program. The CRC will have the opportunity to work on clinical trials that include innovative and cutting-edge therapy of a variety of liver disorders including non-alcoholic fatty liver disease (NASH), autoimmune liver diseases such as Primary Biliary Cholangitis (PBC) and Primary Sclerosing Cholangitis. The successful candidate will join a team CRCs actively conducting Clinical Research under Research Supervisor who oversees operation of the team

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.
Licensure: None.
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

Nice To Haves

Exceptional organizational skills with ability to manage multiple simultaneous studies.
Strong verbal and written communications skills.
In-depth knowledge of FDA, HSR,IRB and GCP Guidelines.
Skills in specimen processing, shipping and handling.
Phlebotomy experience is a plus.

Responsibilities

Independently Coordinate and manage multiple clinical research studies and drug/device trials across academic and health system settings.
Interfaces with study sponsors, monitors to Coordinate and oversee all aspects of clinical research projects, including study start-up, site initiation, study maintenance, monitoring, and close-out visits.
Oversee site visits, address sponsor queries, and ensures strict adherence to study protocols and regulatory requirements throughout all study activities.
Acts as a liaison between patients and physicians, coordinates patient care in compliance with protocol requirements. Dispenses investigational drug and provides patient teaching regarding administration.
Manages logistical and administrative aspects of clinical research projects by maintaining inventory of supplies and equipment, preparing lab kits and requisitions, organizing, and maintaining study documents including regulatory binders and source documents, tracking and deliverables. Responsible for reviewing protocol specific billing guides and submitting billing information; Reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third party payor.
Presents trial concepts and details to the patients, manages participant engagement throughout clinical research studies by identifying and recruiting eligible subjects, conducting informed consent/assent processes, coordinating subject reimbursement, verifying participant eligibility, and serving as the primary point of contact for study-related inquiries and support.
Perform clinical skills including taking vital signs, electrocardiograms and other performing protocol related procedures that may require additional training.
Support the PI and other study staff in following study participants through all study activities to ensure that the study is conducted in compliance with all GCP requirements; provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Collaborates with study team to ensure organize/prioritize workload effectively to meet deadlines
Proficient user of the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic.
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.
Ability to train, guide, and mentor peers