The Rector & Visitors of the University of Virginia
Licensed Clinical Research Coordinator (varying levels), Gastroenterology and He
The Rector & Visitors of the University of Virginia, Charlottesville, Virginia, United States, 22904
The Division of Gastroenterology and Hepatology at the University of Virginia's School of Medicine is currently seeking applicants for 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 licensed CRC 1-3.
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.
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 and deliverables. Review protocol-specific billing guides and submit billing information; reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third party payer. Present trial concepts and details to patients, manage 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 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 the study team to organize and 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 following italicized note has been retained from the original content but presented here as plain text to comply with formatting guidelines: 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 of CRCs actively conducting Clinical Research under a Research Supervisor who oversees operation of the team. Minimum Requirements
Licensure: Must be licensed to practice in a clinical profession such as (but not limited to): Registered Nurse, Athletic Trainer, Pharmacology, Medical Technology, Physical Therapy or Registered Respiratory Therapy. Licensed CRC1
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 CRC2
Education: Bachelor's Degree Required or equivalent combination of experience, education and/or certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse. Experience: At least one year of clinical research experience. Licensed CRC3
Education: Bachelor's Degree Required or equivalent combination of experience, education and/or certifications. Nursing Diploma may substitute for 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 (CRC) 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 job does occasionally require traveling some distance to attend meetings and programs. Salary will be commensurate with education and experience. Learn more about UVA benefits. This is a restricted position, which is dependent on funding and is contingent upon funding availability. This position is based in Charlottesville, VA, and must be performed fully on-site. To learn more about UVA and the Charlottesville area, visit UVA Life and Embark CVA. Background checks, pre-employment health screenings, and drug screenings will be conducted on all new hires prior to employment. This position will not consider candidates who require immigration sponsorship at this time. 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 one 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 completed by UVA's third-party partner, SkillSurvey, during the final phase of the interview. For questions about the application process, please 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. To read more about UVA's commitment to non-discrimination and equal opportunity employment, please visit the UVA Equal Opportunity page.
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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 and deliverables. Review protocol-specific billing guides and submit billing information; reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third party payer. Present trial concepts and details to patients, manage 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 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 the study team to organize and 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 following italicized note has been retained from the original content but presented here as plain text to comply with formatting guidelines: 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 of CRCs actively conducting Clinical Research under a Research Supervisor who oversees operation of the team. Minimum Requirements
Licensure: Must be licensed to practice in a clinical profession such as (but not limited to): Registered Nurse, Athletic Trainer, Pharmacology, Medical Technology, Physical Therapy or Registered Respiratory Therapy. Licensed CRC1
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 CRC2
Education: Bachelor's Degree Required or equivalent combination of experience, education and/or certifications. Nursing Diploma may substitute for Degree for Licensed Registered Nurse. Experience: At least one year of clinical research experience. Licensed CRC3
Education: Bachelor's Degree Required or equivalent combination of experience, education and/or certifications. Nursing Diploma may substitute for 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 (CRC) 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 job does occasionally require traveling some distance to attend meetings and programs. Salary will be commensurate with education and experience. Learn more about UVA benefits. This is a restricted position, which is dependent on funding and is contingent upon funding availability. This position is based in Charlottesville, VA, and must be performed fully on-site. To learn more about UVA and the Charlottesville area, visit UVA Life and Embark CVA. Background checks, pre-employment health screenings, and drug screenings will be conducted on all new hires prior to employment. This position will not consider candidates who require immigration sponsorship at this time. 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 one 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 completed by UVA's third-party partner, SkillSurvey, during the final phase of the interview. For questions about the application process, please 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. To read more about UVA's commitment to non-discrimination and equal opportunity employment, please visit the UVA Equal Opportunity page.
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