University of Virginia
Licensed Clinical Research Coordinator (varying levels), Gastroenterology and He
University of Virginia, Charlottesville, Virginia, United States, 22904
Overview
The Division of Gastroenterology and Hepatology at the University of Virginia’s School of Medicine is seeking Licensed Clinical Research Coordinators (CRC) at varying levels to join a dynamic and growing team. This position is open to applicants who meet the requirements of Licensed CRC 1–3. Key Responsibilities
Independently coordinate and manage multiple clinical research studies and drug/device trials across academic and health system settings. Interface with study sponsors and 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 ensure strict adherence to study protocols and regulatory requirements throughout all study activities. Act as a liaison between patients and physicians, coordinate patient care in compliance with protocol requirements. Dispense investigational drug and provide patient teaching regarding administration. Manage 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 deliverables, and reviewing protocol-specific billing guides; reconcile study billing and identify charges covered by the study versus charges billed to the subject/third party payor. Present trial concepts and details to patients, manage participant engagement, identify and recruit eligible subjects, conduct informed consent/assent processes, coordinate subject reimbursement, verify eligibility, and serve as the primary contact for study-related inquiries and support. Perform clinical skills including taking vital signs, electrocardiograms, and other protocol-related procedures that may require additional training. Support the PI and study staff in following study participants through all study activities to ensure compliance with GCP; provide timely and accurate exchange of participant information with the PI and research team; collaborate to prioritize workload and meet deadlines. Proficient in electronic platforms used in clinical research (e.g., IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms, and Epic). Assist in preparation, maintenance, or creation of study documents such as visit schedules, drug diaries, monitoring or training logs, equipment records, or study communications. Ability to train, guide, and mentor peers. Opportunity to work on clinical trials involving liver disorders (e.g., non-alcoholic fatty liver disease, autoimmune liver diseases) as part of a collaborative CRC team. Minimum Requirements
Licensure:
Must be licensed to practice in a clinical profession (e.g., Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy, or Registered Respiratory Therapy). Licensed CRC 1
Education: Bachelor’s Degree required or equivalent combination of experience, education, and/or certifications. Nursing Diploma may substitute for a degree for Licensed Registered Nurse. Experience: None. Licensed CRC 2
Education: Bachelor’s Degree required or equivalent combination of experience, education and/or certifications. Nursing Diploma may substitute for a degree for Licensed Registered Nurse. Experience: At least one year of clinical research experience. Licensed CRC 3
Education: Bachelor’s Degree required or equivalent combination of experience, education and/or certifications. Nursing Diploma may substitute for a 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. Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. Preferred Qualifications
Exceptional organizational skills with ability to manage multiple simultaneous studies. In-depth knowledge of FDA, HSR, IRB, and GCP guidelines. Skills in specimen processing, shipping and handling. Physical Demands
This is primarily a sedentary job involving extensive use of desktop computers. The role may require traveling to attend meetings and programs. How To Apply
Please apply online by searching for requisition number R0075869. Complete an application with the following documents: Resume Cover Letter Upload all materials into the resume submission field. You can submit multiple documents into this field or combine them into one PDF. Applications without all required documents will not receive full consideration. Internal applicants: Apply through your Workday profile by searching “Find Jobs.” Reference checks will be conducted by UVA’s third-party partner, SkillSurvey, during the final phase of the interview. For questions about the application process, contact Jeremy Brofft, Senior Recruiter at xmf9ad@virginia.edu. The University of Virginia
is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Read UVA’s commitment to non-discrimination and equal opportunity employment.
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The Division of Gastroenterology and Hepatology at the University of Virginia’s School of Medicine is seeking Licensed Clinical Research Coordinators (CRC) at varying levels to join a dynamic and growing team. This position is open to applicants who meet the requirements of Licensed CRC 1–3. Key Responsibilities
Independently coordinate and manage multiple clinical research studies and drug/device trials across academic and health system settings. Interface with study sponsors and 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 ensure strict adherence to study protocols and regulatory requirements throughout all study activities. Act as a liaison between patients and physicians, coordinate patient care in compliance with protocol requirements. Dispense investigational drug and provide patient teaching regarding administration. Manage 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 deliverables, and reviewing protocol-specific billing guides; reconcile study billing and identify charges covered by the study versus charges billed to the subject/third party payor. Present trial concepts and details to patients, manage participant engagement, identify and recruit eligible subjects, conduct informed consent/assent processes, coordinate subject reimbursement, verify eligibility, and serve as the primary contact for study-related inquiries and support. Perform clinical skills including taking vital signs, electrocardiograms, and other protocol-related procedures that may require additional training. Support the PI and study staff in following study participants through all study activities to ensure compliance with GCP; provide timely and accurate exchange of participant information with the PI and research team; collaborate to prioritize workload and meet deadlines. Proficient in electronic platforms used in clinical research (e.g., IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms, and Epic). Assist in preparation, maintenance, or creation of study documents such as visit schedules, drug diaries, monitoring or training logs, equipment records, or study communications. Ability to train, guide, and mentor peers. Opportunity to work on clinical trials involving liver disorders (e.g., non-alcoholic fatty liver disease, autoimmune liver diseases) as part of a collaborative CRC team. Minimum Requirements
Licensure:
Must be licensed to practice in a clinical profession (e.g., Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy, or Registered Respiratory Therapy). Licensed CRC 1
Education: Bachelor’s Degree required or equivalent combination of experience, education, and/or certifications. Nursing Diploma may substitute for a degree for Licensed Registered Nurse. Experience: None. Licensed CRC 2
Education: Bachelor’s Degree required or equivalent combination of experience, education and/or certifications. Nursing Diploma may substitute for a degree for Licensed Registered Nurse. Experience: At least one year of clinical research experience. Licensed CRC 3
Education: Bachelor’s Degree required or equivalent combination of experience, education and/or certifications. Nursing Diploma may substitute for a 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. Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. Preferred Qualifications
Exceptional organizational skills with ability to manage multiple simultaneous studies. In-depth knowledge of FDA, HSR, IRB, and GCP guidelines. Skills in specimen processing, shipping and handling. Physical Demands
This is primarily a sedentary job involving extensive use of desktop computers. The role may require traveling to attend meetings and programs. How To Apply
Please apply online by searching for requisition number R0075869. Complete an application with the following documents: Resume Cover Letter Upload all materials into the resume submission field. You can submit multiple documents into this field or combine them into one PDF. Applications without all required documents will not receive full consideration. Internal applicants: Apply through your Workday profile by searching “Find Jobs.” Reference checks will be conducted by UVA’s third-party partner, SkillSurvey, during the final phase of the interview. For questions about the application process, contact Jeremy Brofft, Senior Recruiter at xmf9ad@virginia.edu. The University of Virginia
is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Read UVA’s commitment to non-discrimination and equal opportunity employment.
#J-18808-Ljbffr