Clinical Research Coordinator 2, Joint Emerging Diseases Initiative (JEDI)

UVA Health

1d•Onsite

About The Position

The Division of Infectious Diseases & International Health at the University of Virginia (UVA) School of Medicine is seeking applicants for a Clinical Research Coordinator 2 (CRC), non-licensed or licensed, to join the JEDI clinical trials team. This role involves assisting with the oversight of multiple clinical research projects. A CRC 2 is expected to plan, organize, lead, and perform comprehensive and advanced-level clinical research duties for multiple and/or complex clinical trials. The preferred candidate will directly impact the overall efficiency, productivity, and success of each clinical trial they coordinate, working 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, the CRC will work closely with the Clinical Research Manager, other CRCs, and several physician-investigators. The role requires managing multiple complex clinical trials simultaneously in accordance with current regulatory requirements and maintaining all study documentation in an 'audit ready' manner. The position involves working with Principal Investigators and other research team members specializing in pulmonary and infectious diseases, with a varied research portfolio including industry-sponsored and NIH-funded studies on acute COVID-19, Long-COVID, Viral Pneumonia, and ARDS. This is an exempt-level, benefited position, dependent on funding, and must be performed fully on-site in Charlottesville, VA.

Requirements

Bachelor's Degree Required or equivalent combination of experience, education and or certifications (for Non-Licensed CRC 2 and Licensed CRC 2)
At least one year of clinical research experience (for Non-Licensed CRC 2 and Licensed CRC 2)
Nursing Diploma may substitute for Degree for Licensed Registered Nurse (for Licensed CRC 2)
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 (for Licensed CRC 2)
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)
Background checks, pre-employment health screenings, and drug screenings will be conducted on all new hires prior to employment
Will not consider candidates who require immigration sponsorship now or in the future

Nice To Haves

Some experience in a healthcare setting and/or knowledge of medical terminology
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

Responsibilities

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
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
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
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
Other duties may be assigned