| Posting Summary: The Department Pediatrics, Division of Endocrinology at the University of Virginia is seeking a highly motivated Clinical Research Coordinator, Licensed. The incumbent works collaboratively with trial Principal Investigators, IRB, the University, sponsors, and human subjects to ensure efficient and accurate progress of multiple clinical trials from the planning stage through trial completion and post-study closure. Incumbent is responsible for submitting and revising protocols, as well as preparing reports, renewal forms, and other required forms for the IRB and other appropriate review boards for review and approval of research conducted. Incumbent also recruits, screens, and enrolls patients into clinical trial studies; maintains study data; and follows-up per standards of Good Clinical Practices. Position provides quality assurance and regulatory maintenance for studies. The incumbent must be able to function with a high level of autonomy in decision-making related to patient screening, consent, follow-up, data collection and trial communication to all parties.|
Qualified candidate must have a Associate's degree or higher in Nursing or a related field and at least one year of clinical research experience. RN required. Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification preferred. Bachelor's degree with 2-3 years' experience as a clinical research coordinator in a health care environment preferred.
Incumbent must have the ability to perform physical exams, including assessing vital signs and administering prescribed medications; ability to work accurately with attention to detail; excellent written, interpersonal and verbal communication skills. Proficiency in MS Office (Outlook, Word, and Excel) is required. Experience with MS Access is preferred.
This is a 20-hour per week wage position.
Required Minimum Level of Education: *Degree Required
Required Specific Degree/Training: Associate's degree or higher in Nursing or a related field.
Preferred Minimum Level of Education: *Degree Preferred
Preferred Specific Degree/Training: Bachelor's Degree
Required Minimum Level of Experience: Some - up to 4 years
Required Specific Experience: At least one year of clinical research experience is required.
Preferred Minimum Level of Experience: Some - up to 4 years
Preferred Specific Experience: Work experience in a health care environment with 2-3 years' experience as a clinical research coordinator preferred.
Required License or Certification: RN required.
Preferred License or Certification: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification preferred.
Required Knowledge, Skills and Abilities: 1. Ability to manage multiple clinical trials simultaneously.
2. Knowledge of clinical research, human subjects research ethics, and IRB procedures.
3. Ability to follow set laboratory policies and procedures.
4. Ability to work accurately with attention to detail; excellent written, interpersonal, and verbal communication skills.
5. Ability to accurately and consistently prepare and submit regulatory documentation.
6. Ability to interact with patients, family members, physicians, and ancillary personnel, as well as research committees and outside sponsor personnel, in a professional manner.
7. Knowledge of medical terminology associated with diseases/conditions under study.
8. Ability to perform physical exams, including assessing vital signs and administering prescribed medications.
9. Ability to work independently and as part of a team.
10. Ability to identify and resolve problems.
11. Ability to sort and compile data.
12. Ability to maintain confidentiality at all times.
13. Knowledge of Good Clinical Practices for research.
Preferred Knowledge, Skills and Abilities: 1. Knowledge of Federal and State regulations as they apply to the conduct of clinical research.
2. Strong working knowledge of UVA IRB-HSR policies.
Required Computer Applications: MS Office (Word, Excel, Outlook) and Internet.
Preferred Computer Applications: Microsoft Access