The coordinator will manage multiple complex clinical trials from start-up through archiving, including patient recruitment and regulatory documentation. They will collaborate with physicians and sponsors to ensure trials are conducted according to FDA and NIH requirements.
Requirements summary
A Bachelor's degree and at least one year of clinical research experience are required. Licensed candidates must hold a professional clinical license such as RN or Respiratory Therapy.
bachelor degreeprofessional certificateRegulatory CompliancePhlebotomyMedical TerminologyData ManagementElectronic Medical RecordsPatient RecruitmentSafety ReportingInformed ConsentIRB SubmissionsBudget NegotiationClinical Trial CoordinationClinical Research Oversight
Job description
The Division of Infectious Diseases & International Health at the University of Virginia (UVA) School of Medicine is currently seeking applicants for a Clinical Research Coordinators (CRC), non-licensed or licensed, that has the skill and experience of a CRC 2 to join the JEDI clinical trials team to assist with oversight of multiple clinical research projects.
A Clinical Research Coordinator 2 will be expected to plan, organize, lead, and perform comprehensive and advanced level clinical research duties for multiple and / or complex clinical trials.
Our preferred candidate for this position will have the ability to directly impact the overall efficiency, productivity and success of each clinical trial they coordinate.
The CRC will work closely with physicians, research staff, study subjects, and departmental staff.
The successful candidate will be responsible for coordinating all aspects of clinical research from study start-up through archiving of study records.
As a key member of the research team, you will work closely with the Clinical Research Manager, other CRCs and several physician-investigators on our research trials.
The successful candidate will be required to manage multiple complex clinical trials simultaneously in accordance with current regulatory requirements and maintain all study documentation in a manner that is ‘audit ready’.
This position works closely with Principal Investigators and other research team members who specialize in the management of pulmonary and infectious diseases.
We have a varied research portfolio including industry-sponsored and NIH-funded studies.
Currently we have 2 inpatient trials (ARDS & Viral PNA), 1 acute COVID outpatient trial, 2 Long COVID outpatient trials in close-out and soon we will have 3 new Long COVID trials in startup.
CRCs will have the opportunity to work on clinical trials that include new therapies for acute COVID-19, Long-COVID, Viral Pneumonia and ARDS.
The successful candidate will be expected to: Screen electronic medical records (EMR) for potential study candidates & track screening efforts.
Recruit and obtain informed consent from study participants and maintain telephone and in-person contact Manage ongoing study conduct activities such as: coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments.
Benefits
Health Insurance
Work closely with Principal Investigators and other study team members on all clinical research projects assigned.
Notify PI and/or supervisor of any potential issues with the study or subject status.
Able to work with minimal supervision.
Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
Facilitate and / or complete activities required for study start-up including: contract and budget negotiations, regulatory submissions and all communications with the study Sponsor.
Coordinate multiple clinical trials or research projects simultaneously or manage large individual clinical trials that may be multicenter and complex in nature.
Manage all aspects of ongoing clinical trial conduct from enrollment to off-study visits, data management, safety reporting and compliance oversight.
Prepare and submit all regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, protocol modifications, adverse event reports, unanticipated events.
Reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third party payor Orient and/or provide basic training to new study team members.
Ensure Sponsor is invoiced for study activity and reconcile payments received.
Notify PI and / or supervisor of any potential issues with the study or subject status.
Communicate effectively with study Sponsor(s).
Liaise with the other Departments within the institution to support clinical research activities.
Demonstrate a high level of proficiency with the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic.
Support investigator-initiated research activity by conducting literature searches, collating research material, assisting with abstract or manuscript preparation.
Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning.
Process, prepare and ship study research samples Ability to work a flexible schedule, when needed, given the nature of the studies open to enrollment Ability to work on weekends, when needed, given the nature of the studies open to enrollment Ability to enroll COVID positive patients in the inpatient or outpatient settings Ability to draw blood when necessary, or become phlebotomy trained Support and providing guidance to faculty and trainees with clinical research projects in the department.
In addition to the above job responsibilities, other duties may be assigned.
MINIMUM REQUIREMENTS Non-Licensed CRC 2 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.
Licensed
CRC 2
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.
Licensure
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. 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.
Preferred experience: At least one year of clinical research experience as a CRC with informed consent experience. Previous experience with EPIC EMR, collection and processing of blood draws for research. EMT/phlebotomy training, previous experience with OnCore, CRConnect, IRB-HSR, Advarra, and wcg IRB, iMEdidata RAVE, REDCap. Previous experience managing several open clinical trials at the same time. Previous experience consenting patients into clinical trials. Regulatory experience is a plus.
Required knowledge, skills and abilities: Excellent interpersonal, verbal and written communication skills. Excellent attention to detail. Comfortable using technology. Good problem-solving skills. Ability to work independently and as part of a team. Ability to switch tasks and thrives in a fast-paced environment. Ability to prioritize competing tasks and take initiative. Ability to plan and execute tasks and projects while maintaining flexibility and keeping the team abreast of status. Effective use of Microsoft Office (Word, Excel, PowerPoint, and Outlook). Salary will be commensurate with education and experience. This is an exempt-level, benefited position. 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. About UVA and the Community To learn more about UVA and in the Charlottesville area, visit UVA Life and Embark CVA. Additional Requirements 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 now or in the future.
How To Apply
Please apply online, by searching for requisition number R0082739. 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: Search and apply for jobs on the UVA Internal Careers website. Reference Check Process Reference checks will be completed by UVA’s third-party partner, SkillSurvey, during the final phase of the interview. Five references will be requested, with at least three responses required. Contact For questions about the application process, please contact Jeremy Brofft, Senior Academic 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. Learn more about UVA’s commitment to non-discrimination and equal opportunity employment.
