Opportunities for cancer patients to enroll in clinical trials within the Cancer Center, at the University of Virginia School of Medicine, are increasing. In order to meet the needs of our patients, the Cancer Center is looking for several Clinical Research Intermediate, Non-licensed, coordinators to assist with the coordination and management of clinical trials in cancer. This position may serve as a CRC for various oncology study teams; working with principal investigators within the Cancer Center.
The incumbent works with the Principal Investigator, human subjects, IRB, University and the company and/or government sponsor to ensure smooth, accurate progress of clinical trials from the planning stage through trial completion and post-study closure. Duties include budget preparation and support of financial accountability, coordination of subject recruitment and consent, supervision of the scheduling of study procedures and research visits, and collection of study data. Position, in keeping with licensure, collects specimens and monitors subjects, provides quality assurance and regulatory maintenance for studies, and may assist in the reporting of test results.
Successful Candidates will hold a Bachelor's degree. A minimum of four years of clinical research experience is required. Graduate degree may substitute for two years of experience.
Certification as a Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) is preferred and is required within one year of eligibility.
This position is restricted and is contingent upon the continuation of funding.
This position will remain open to applications until filled.
To apply for this position, please complete an application online, and attach a cover letter, resume/CV, and contact information for three references.
For information related to this posting, please contact Heather Lothamer, at firstname.lastname@example.org.
Clinical Research Coordinators Intermediate, Non-Licensed, perform a full range of clinical research duties and have an advanced knowledge of the clinical research process and the regulations that govern it. They function under the Principal Investigator's medical license and cannot perform any tasks that by state or local law require a license to perform.
They perform progressively more complex and comprehensive clinical research duties at an ever-increasing level of authority, working closely with the Principal Investigator. They work independently and have the authority to adapt methods and procedures to meet the needs of the clinical trial. They are focused on the long term goals of clinical research trial and process. They may direct, lead, or supervise the activities of others.
Assist Principal Investigator in developing clinical trial protocols, and submit the required documentation to the Institutional Review Board, the University, and corporate or government sponsors.
Coordinate multiple clinical trials simultaneously or clinical trials with unique complexity.
Conduct literature searches, correlate research material, and assist in writing scientific articles and papers.
Serve as the liaison to the sponsor for assigned studies.
Support the orientation and training of new research team members and other staff.
May supervise other clinical researchers, support staff, or students.
Order and maintain supplies, and make day-to-day decisions in support of the study.
Perform all duties of the Clinical Research Coordinator, Non-Licensed.
In addition to the above job responsibilities, other duties may be assigned.
Required Education: Bachelor's degree.
Preferred Education: Master's degree
Required Experience: A minimum of four years of clinical research experience is required. Graduate degree may substitute for two years of experience.
Preferred License or Certification: Certification as a Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) is preferred and is required within one year of eligibility.
Required Knowledge, Skills and Abilities:
1.Demonstrated consistent ability to communicate exceptionally in both written and verbal forms.
2.Ability to accurately and consistently document information.
3.Ability to work as a part of a collaborative team, as well as independently, and with attention to detail.
4.Ability to interact with patients, family members, physicians, and ancillary personnel, as well as research committees and outside sponsor personnel, in a professional manner.
5.Considerable knowledge of scientific principles and research methodology; proficient knowledge of medical terminology with the ability to manage large amounts of information.
6.Ability to maintain confidentiality at all times.
7.Ability to manage multiple clinical trials simultaneously.
8.Ability to identify and resolve problems.
9.Ability to sort and compile data.
10. Knowledge of Good Clinical Practices for research.
Preferred Knowledge, Skills and Abilities: Knowledge of Federal and State regulations as they apply to the conduct of clinical research.
Required Computer Applications: MS Office (Word, Excel, Outlook)
Preferred Computer Applications: Microsoft Access, Epic
The University of Virginia, including the UVA Health System and the University Physician's Group 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, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.