- Assist Principal Investigator in developing clinical trial protocols and submit the required documentation to the Institutional Review Board, the University, federal regulators in industry, or government sponsor.
- Manage multiple Principal Investigator relationships with internal and external research stakeholders.
- Provide guidance and assistance to Principal Investigators for grant submissions and research compliance oversight to ensure full compliance with local, state, and federal policies and procedures.
- Demonstrate a working knowledge of the regulatory framework for FDA and non-FDA regulated studies.
- Prepare and submit all types of clinical research documentation to the IRB of record (central or local) for review and approval.
- Assist with preparation for internal or external compliance audits
- Oversee study invoice and billing reconciliation.
- Demonstrate a high level of proficiency with and ability to train other CRCs and/or student workers on the various electronic platforms utilized in clinical research such as: Huron, IRB Pro, Protocol Builder, CRConnect, OnCore, REDCap, e-regulatory platforms and Epic.
- Coordinate clinical research education, training and/or orientation for new CRCs, clinical research interns and/or student workers.
- Coordinate and manage all aspects of clinical trial conduct for multiple ongoing clinical trials of any level of complexity.
- Facilitate and/or complete activities required for study start-up.
- Proven ability to work independently with minimal supervision
- 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.
- Previous experience with EPIC EMR, collection and processing of blood draws for research.
- Previous experience with OnCore, Advarra, and wcg IRB.
- Previous experience managing several open clinical trials at the same time.
- Excellent interpersonal and communication skills.
- Ability to work independently and as part of a team.
- 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.
- Strong analytical skills.
- CV
- Cover letter
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Clinical Research Coordinator 3 or 4, Department of Pediatrics UVA - Charlottesville, United States - University of Virginia
Description
The Department of Pediatrics at the University of Virginia (UVA) School of Medicine is currently seeking applicants to join their team in a new role in the Clinical Research Core.
This candidate will join a dynamic, growing team of clinical research professionals.This position is open to applicants who meet the requirements of Clinical Research Coordinator (CRC) 3, or 4 in a Licensed or Non-Licensed role.
As a key member of the clinical research team, you will work closely with the Clinical Research Operations Manager.The primary focus of this role will be to provide support for core clinical research functions across divisions such as:
regulatory, Huron submissions, CRC training and / or orientation, support for UVA clinical research platforms as needed.
Many of the responsibilities of this role will lend themselves to working remotely; however, the successful candidate should be available to work onsite on UVA Grounds as needed.
The successful candidate will be expected to:
Qualified candidates must have:
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, LicensedEducation:
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-LicensedEducation:
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 (CCRC) and/or Certified Clinical Research Professional (CCRP) is preferred at the time of hire and is required within one year.
Clinical Research Coordinator 4, LicensedEducation:
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.
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:
Required knowledge, skills and abilities:
Physical demands:
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.
The Clinical Research Coordinator 3 or 4 will report to the Clinical Research Operations Manager. For additional information about the position, please contact Monika Thielen ART, BComm at
This position is located in Charlottesville, VA. This position is a restricted position and is dependent upon project need, availability of funding and performance. This is an exempt-level, full-time, benefited position. For more information on the benefits at UVA, visit The position will remain open until filled. 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:
Complete an application online with the following documents:
PROCESS FOR INTERNAL UVA APPLICANTS:
Please apply through your Workday Home page, search "Find Jobs", and search for
R
PROCESS FOR EXTERNAL APPLICANTS:
Please visit UVA job board: and search for R
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 Christi Maguire Recruiting Specialist, at please reference job requisition R
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.
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.
