Clinical Research Coordinator 2-4, Joint Emerging Diseases Initiative (JEDI)

University of Virginia; Charlottesville (VA); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking Clinical Research Coordinators to join their dynamic team in the fight against infectious diseases. This role offers the chance to work closely with world-renowned researchers and manage a diverse portfolio of clinical trials, including studies on COVID-19 and other critical health issues. The ideal candidate will demonstrate strong organizational skills, a commitment to regulatory compliance, and the ability to thrive in a fast-paced environment. This position not only promises professional growth but also the opportunity to make a tangible impact on public health through innovative research initiatives.

Qualifications

• Bachelor's degree required; clinical research experience preferred.
• Strong communication and problem-solving skills are essential.

Responsibilities

• Coordinate all aspects of clinical research from start-up to archiving.
• Manage multiple complex clinical trials and maintain documentation.

Skills

Clinical Research Coordination

Regulatory Knowledge

Interpersonal Communication

Problem-Solving

Attention to Detail

Time Management

Education

Bachelor's Degree

Tools

EPIC EMR

Microsoft Office

IRB Pro

OnCore

CRConnect

Job description

The Division of Infectious Diseases and International Health at the University of Virginia (UVA) School of Medicine is currently seeking applicants for Clinical Research Coordinators (CRC), non-licensed or licensed, at various skill and experience levels (CRC 2 or 3) to join the JEDI clinical trials team to assist with oversight of multiple clinical research projects. A Clinical Research Coordinator 2 or 3 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 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 world-renowned 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, 2 outpatient trials, 4 studies in close-out and 2 new trials in start-up. 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.
• 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:

Clinical Research Coordinator 2, Non-Licensed
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.

Clinical Research Coordinator 2, Licensed
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.

Clinical Research Coordinator 3, Non-Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education, and/or certifications.
Experience: Minimum of 3 years of clinical research experience required. Master’s degree may substitute for 1 year of clinical research experience.
Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.

Clinical Research Coordinator 3, Licensed
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.
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.

Clinical Research Coordinator 4, Non-Licensed
Education: Bachelor's Degree Required or equivalent combination of experience, education, and/or certifications.
Experience: At least seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master’s or other advanced degree may substitute for one year of clinical research experience. Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire.

Clinical Research Coordinator 4, Licensed
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 seven years of clinical research experience demonstrating progressive levels of responsibility and complexity of work. Master’s or other advanced degree may substitute for one year of clinical research experience.
Licensure: Clinical Research Coordinator (CCRC) and/or Certified Clinical Research Professional (CCRP) is required within one year of hire. 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.

Preferred 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.
• 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) is required.
• Previous experience with EPIC EMR, collection of biomarkers such as blood draws, and experience in a clinical environment.
• Must be able to communicate clearly and enjoy talking to people to gain trust and explain concepts in lay terms.
• Must agree to download several UVA apps on to personal phone to help with trial management.

PHYSICAL DEMANDS:

This job requires extensive computer work, patient interaction, and the ability to traverse the footprint of the UVA medical center. Occasional travel to other UVA clinics. The job does occasionally require traveling some distance to attend meetings, and programs.

This position is a restricted position and is dependent upon project need, availability of funding and performance. This is an Exempt level, benefited position, and is not a VISA supported position. For more information on the benefits at UVA, visit hr.virginia.edu/benefits.

Priority review of applications will begin March 6th, 2025, but the position will remain open until filled. This position is located in Charlottesville, VA. This position will not sponsor applicants for work visas. The anticipated hiring range is commensurate with education and experience.

The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen and drug screening are required for this position prior to employment.

To Apply:

Apply Here, and search for R0069864.

Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs' and search for R0069864 .

Complete an application online with the following documents:

·CV

·Cover letter

Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all required documents will not receive full consideration.

References will be completed via UVA’s standardized process Skill Survey. A total of five references will be requested via SkillSurvey during the final phase of the interview process.

For questions about the application process, please contact Michelle Johnson, Recruiting Specialist, at [e-mail].