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University of Virginia · 4 months ago

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

Charlottesville, VA

Full-time

Onsite

Entry Level

1+ years exp

The University of Virginia's Division of Gastroenterology and Hepatology is seeking non-licensed Clinical Research Coordinators at various skill levels to join their clinical research team. The role involves coordinating clinical trials, managing study logistics, and ensuring compliance with protocols while collaborating closely with Principal Investigators and other team members.

Higher Education

No H1B

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

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

Qualification

Clinical research experienceGCP guidelinesElectronic platforms proficiencyVerbalFDA guidelinesOrganizational skillsWritten communicationPhlebotomy experienceSpecimen processing skillsTrainingMentoring skills

Required

Bachelor's Degree Required or equivalent combination of experience, education and or certifications

At least one year of clinical research experience for Clinical Research Coordinator 2

Minimum of 3 years of clinical research experience required for Clinical Research Coordinator 3

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