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University of Virginia · 4 months ago

Licensed Clinical Research Coordinator (varying levels), Gastroenterology and Hepatology

Charlottesville, VA

Full-time

Onsite

New Grad, Entry Level

The University of Virginia's Division of Gastroenterology and Hepatology is seeking licensed Clinical Research Coordinators at various skill and experience levels to join their team. The role involves managing clinical research studies, coordinating with sponsors, and ensuring compliance with study protocols while providing support to patients and the research team.

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

Qualification

Clinical Research CoordinationGCP GuidelinesFDA RegulationsElectronic PlatformsClinical SkillsSpecimen ProcessingPatient InteractionOrganizational SkillsMentoringTeam Collaboration

Required

Must be 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

Bachelor's Degree Required or equivalent combination of experience, education and or certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse

Licensed CRC1: Experience: None

Licensed CRC2: Experience: At least one year of clinical research experience

Licensed CRC3: 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

Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire