Clinical Research Coordinator, Licensed/Non-Licensed
Charlottesville
Clinical Research Coordinator, Licensed/Non-Licensed
R0036183
Charlottesville, Virginia, United States
Research
The University of Virginia
The Department of OBGYN is seeking an experienced Clinical Research Coordinator to join our Gynecological Oncology team. A Clinical Research Coordinator 3/4, Licensed/Non-Licensed (CRC-3, L/NL/CRC-4L/NL), performs a full range of clinical research duties with minimal supervision.
A CRC 3 has an advanced level of knowledge of clinical research conduct, good clinical practices as well as federal and state regulations that govern it. A CRC 3 performs progressively more complex and comprehensive clinical research duties with an increasing level of autonomy and works closely with a Principal Investigator(s) and other members of the research team.
A CRC 4 has the ability to directly impact the overall efficiency, productivity, and success of each clinical trial they coordinate. The CRC in this role is able to work independently and has the authority to interact with internal or external stakeholders involved in a clinical trial or modify clinical trial workflow or processes within her respective department or division to meet the needs of a given study. A CRC in this role may manage or support a research team of CRCs.
Job Description:
Work closely with Principal Investigators and other study team members on all clinical research projects assigned.
Able to work with minimal supervision.
Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
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.
Reconcile study billing, identify charges covered by the study, versus charges to be billed to the subject/third-party payer
Orient and/or provide basic training to new study team members.
Notify PI and/or supervisor of any potential issues with the study or subject status.
Communicate effectively with study Sponsor(s).
Liaise with other groups in the cancer center to support clinical research activities and effectively run multi-disease trials across the cancer center.
Demonstrate a high level of proficiency with the various electronic platforms utilized in clinical research such as IRB Pro, Protocol Builder, OnCore, iMedidata, Inform, Openclinica, Epic, and other data management platforms.
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.
Additional duties for CRC 4:
Manage multiple Principal Investigator relationships with internal and external research stakeholders.
Serve as the primary liaison with the Sponsor for assigned studies.
Coordinate and manage all aspects of clinical trial conduct for multiple ongoing clinical trials of any level of complexity.
Participate in planning and analysis of research portfolios, in conjunction with department management and Principal Investigators.
May manage a team of Clinical Research Coordinators and/or laboratory or research support staff, with responsibilities that include hiring, scheduling, workload, compensation, rewards, professional development, and performance management.
Qualifications to be considered at a Clinical Research Coordinator 3, Licensed:
Education: Associate’s degree required, Bachelor’s or Master’s Degree Preferred. Five or more years of clinical research experience may be considered in lieu of a degree.
Experience: Minimum of 3 years of clinical research experience required. A 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. Licensed to Practice in Clinical Professions such as (but not limited to): Registered Nurse, Pharmacology, Medical Technology, or Physical Therapy.
Qualifications to be considered at a Clinical Research Coordinator 4, Licensed:
Education: Associate’s Degree Required; Bachelor’s or Master’s Degree Preferred. Nursing Diploma may substitute for Associate’s 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 preferred at the time of hire and is required within one year. Licensed to Practice in Clinical Professions such as (but not limited to): Registered Nurse, Athletic Training, Pharmacology, Medical Technology, Physical Therapy or Registered Respiratory Therapy.
Qualifications to be considered at a Clinical Research Coordinator 3, Non-Licensed:
Education: Associate degree required, Bachelor’s or Master’s Degree Preferred. Five or more years of clinical research experience may be considered in lieu of a degree.
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.
Qualifications to be considered at a Clinical Research Coordinator 4, Non-Licensed:
Education: Bachelor's degree required, Master’s or other advanced degree preferred.
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 (CRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.
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 .
This position will remain open until filled. University will perform background checks on all new hires prior to employment. A completed pre-employment health screen is required for this position prior to employment.
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.
To Apply:
Please apply through Workday , and search for R0036183. Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'. 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 Skill Survey during the final phase of the interview process.
For questions about the application process, please contact Eric Allen, Academic Recruiter at uth9qh@virginia.edu .
For more information about UVA and the Charlottesville community please see http://www.virginia.edu/life/charlottesville and https://embarkcva.com/ .
COVID Vaccination Requirement and Guidelines
Please visitthe UVA COVID-19 Job Requirements and Guidelines webpageprior to applying for current information regarding vaccination requirementsandguidelines for employment at UVA.
The University of Virginia, i ncluding 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.
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