Clinical Research Trainee and Coordinator - Charlottesville, United States - University of Virginia

Description

The University of Virginia Department of Anesthesiology within in the School of Medicine is seeking two Clinical Research Coordinators, Licensed or Non-licensed at the trainee (CRC-1) and/or coordinator (CRC-2) level.

Research, both clinical and basic, is an essential part of the field of anesthesiology and is the road by which the specialty progresses.

It is, therefore, also an essential part of the mission of the Department of Anesthesiology.

The Clinical Research Coordinators (CRC-1/CRC-2) will conduct a variety of clinical trial activities, which will vary depending on whether the individual hired is licensed or non-licensed.

The Clinical Research Coordinators (CRC-1/CRC-2) works closely with our Vice Chair for Clinical Research, departmental clinicians and other research staff, is integrally involved in most steps of the research trial process and available to work with study patients.

Responsibilities:

Clinical Research Trainee (CRC-1):

• Become familiar with study start-up processes and requirements for: non-disclosure agreements, data use and material transfer agreements, clinical trial agreements, development of clinical trial budgets.
• Manage study recruitment and enrollment efforts including screen and identify eligible patients, obtain and document informed consent and enrollment.
• Manage ongoing study conduct activities such as: schedule and coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments.
• Collect and enter study data in a timely fashion, maintain corresponding documentation
• Collect, process, store and ship study specimens as needed.
• 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.
• Prepare and submit all regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, protocol modifications, adverse event reports, unanticipated events.
• Document and report protocol deviations.
• Reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third party payor.
• Confirm Sponsor is invoiced for study activity.
• Notify PI and/or supervisor of any potential issues with the study or subject status.
• Communicate effectively with study Sponsor(s.)
• Proficient user of the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic.
• Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning.
• In addition to the above job responsibilities, other duties may be assigned.

Clinical Research Coordinator (CRC-2):

• Work closely with Principal Investigators and other study team members on all clinical research projects assigned.
• Become familiar with study start-up processes and requirements for: non-disclosure agreements, data use and material transfer agreements, clinical trial agreements, development of clinical trial budgets.
• Manage study recruitment and enrollment efforts including: screen and identify eligible patients, obtain and document informed consent and enrollment.
• Manage ongoing study conduct activities such as: schedule and coordinate study visits, maintain concomitant medication records, track and report adverse events, organize subject study payments.
• Collect and enter study data in a timely fashion, maintain corresponding documentation
• Collect, process, store and ship study specimens as needed.
• 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.
• Prepare and submit all regulatory documentation to the IRB such as: personnel changes, annual protocol continuations, protocol modifications, adverse event reports, unanticipated events.
• Document and report protocol deviations.
• Reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third party payor.
• Confirm Sponsor is invoiced for study activity.
• Notify PI and/or supervisor of any potential issues with the study or subject status.
• Communicate effectively with study Sponsor(s.)
• Proficient user of the various electronic platforms utilized in clinical research such as: IRB Pro, Protocol Builder, CRConnect, OnCore, e-regulatory platforms and Epic.
• Demonstrate a continuously increasing level of clinical research knowledge gained through active participation in training and mentorship opportunities as well as self-guided learning.
• In addition to the above job responsibilities, other duties may be assigned.

Candidates must have excellent interpersonal skills, as well as the ability to plan and execute tasks; strong organizational skills; the ability to clearly articulate specific information to clinicians.

Excellent oral communication and the ability to keep detailed records are essential.

Preference is given to candidates with a working knowledge of clinical research and/or acute care hospital patients and medical terminology.

Minimum Requirements:
Clinical Research Trainee (CRC-1), Non-Licensed

• Education: Bachelor's or associate degree. Four years of relevant work experience may be considered in lieu of a degree.
• Experience: None.

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

• Licensure: None

.

Clinical Research Trainee (CRC-1), Licensed

• Education: Associate's degree required; Bachelor's Degree Preferred. Nursing Diploma may substitute for Associate's Degree for Licensed Registered Nurse.
• Experience: None.
• Licensure: RN or other health-related licensure as dictated by study.
• Clinical Research Coordinator (CRC-2) Non-Licensed
• Education: Associate's degree required, Bachelor's Degree Preferred. Four years of clinical research experience can be considered in lieu of a degree.
• Experience: At least one year of clinical research experience. Some experience in a healthcare setting and/or knowledge of medical terminology is preferred.
• Licensure: None

Clinical Research Coordinator (CRC-2), Licensed

• Education: Associate's Degree Required; Bachelor's Degree Preferred. Nursing Diploma may substitute for Associate's Degree for Licensed Registered Nurse.
• Experience: At least one year of clinical research experience.
• Licensure: RN or other health-related licensure as dictated by study.

Anticipated Hiring Range:
Salary commensurate with qualifications and experience, with UVA benefits.

For additional information about the position, please contact Marcia "Cricket" Birk, at

This position will remain open until filled. This position is a restricted position and is dependent upon project need, availability of funding, and performance. The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen and a drug screen are required for this position prior to employment.


TO APPLY:

External applicants:

Please visit the UVA job board and search for R Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'.

All applicants must complete an application online and attach the following required documents:

• CV
• Cover letter
• Contact Information for three [3] References (name, email address, and mobile phone number).

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.

For questions about the application process, please contact Ashley Cochran, Senior Recruiter at

For more information about UVA and the Charlottesville community please see and

The University of Virginia, including the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician's Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff.

We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers.

All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.