Regulatory Clinical Research Trainee
- Location: Charlottesville, VA
- Posted: Jul 15, 2019
The Cancer Center Office of Clinical Trials, at the University of Virginia School of Medicine, is seeking a Regulatory Clinical Research Trainee. This position assists in the coordination and management of all regulatory aspects of clinical trials. Incumbent trains with other clinical research regulatory staff with respect to the details of all assignments, which include all or parts of regulatory controls, records management, and protocol compliance and development.
Specifically, after training, the regulatory trainee must demonstrate a basic understanding of the clinical research process and the regulations, both federal and local, governing the conduct of clinical research. They should also be able to independently manage all regulatory submissions for trials assigned to them from approval to close-out. After one year of employment, the trainee will be evaluated based on established criteria for possible promotion to the next level.
This position is restricted and contingent upon the continuation of funding and other factors.
EXTERNAL APPLICANTS: please apply through Workday at the following URL, https://uva.wd1.myworkdayjobs.com/UVAJobs , and search for requisition # R0006768. Complete an application online and attach a cover letter, CV/resume, and contact information for three references (name, email address, telephone number, address).
INTERNAL UVA APPLICANTS: please apply through your Workday Home page, search Find Jobs, and search for requisition # R0006768. Complete an application online and attach a cover letter, CV/resume, and contact information for three references (name, email address, telephone number, address).
Clinical Research Trainees learn and assist with a variety of clinical activities, including work with laboratory specimens, document preparation, record keeping, materials preparation, and review of prospective research participants. Clinical Research Trainees perform work at the task level under close supervision. Responsibilities can include:
Receive training in proper research protocol compliance and development, including regulatory controls, study procedures, and data management. Work closely with Clinical Research Coordinators and Principal Investigators to learn the full scope of clinical research duties.
Assist in preparation of documentation, reports, graphs, and other materials, keeping appropriate logs, tracking participants, and preparing study materials.
Under direct supervision, perform a variety of tasks, such as assisting in recruitment and screening of prospective research participants, obtaining informed consent from study participant, collecting, entering, and analyzing subject data; and compiling reports.
Process, prepare, and ship laboratory specimens.
To be promoted, trainees must demonstrate a basic understanding of the clinical research process and the regulations, both federal and local, governing the conduct of clinical research.
In addition to the above job responsibilities, other duties may be assigned.
Education: A Bachelor's degree is required.
Licensure: Licensure is dependent on research study requirements.
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require walking some distance to attend meetings, and programs.
The University of Virginia, including the UVA Health System and the University Physicians 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.
- Full time