Clinical Research Coordinator 2-3, Joint Emerging Diseases Initiative (JEDI)

University of Virginia•Charlottesville, VA

5d•$62,000 - $90,000•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 (CRC), non-licensed or licensed, with the skill and experience of a CRC2 or CRC3 to join the JEDI clinical trials team. The CRC will be responsible for planning, organizing, leading, and performing comprehensive and advanced level clinical research duties for multiple and/or complex clinical trials. The preferred candidate 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, 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 successful candidate will manage multiple complex clinical trials simultaneously in accordance with current regulatory requirements and maintain all study documentation in an 'audit ready' manner. This position works closely with Principal Investigators and other research team members specializing in the management of pulmonary and infectious diseases, with a varied research portfolio including industry-sponsored and NIH-funded studies. Current trials include ARDS & Viral PNA inpatient trials, an acute COVID outpatient trial, and several Long COVID outpatient trials in close-out and startup phases. CRCs will have the opportunity to work on clinical trials involving new therapies for acute COVID-19, Long-COVID, Viral Pneumonia, and ARDS.

Requirements

Bachelor's Degree Required or equivalent combination of experience, education and or certifications.
At least one year of clinical research experience (for CRC 2).
Minimum of 3 years of clinical research experience required (for CRC 3).
Master’s degree may substitute for 1 year of clinical research experience (for CRC 3).
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).
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year (for Non-licensed CRC 3).
Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire (for Licensed CRC 3).
Some experience in a healthcare setting and/or knowledge of medical terminology is preferred (for Non-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).

Nice To Haves

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.
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.
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.