UTS-Temporary Regulatory Assistant Details

UTS-Temporary Regulatory Assistant

University of North Carolina at Chapel Hill - Chapel Hill, NC

Employment Type : Full-Time

Position Type Temporary Staff (SHRA)
Job Title UTS-Temporary Regulatory Assistant
Department Name HR UTS Partnership
Vacancy ID S018255
Position Posting Category Research Professionals
Hiring Range $21.00-$23.00
Full-time/Part-time Full-Time Temporary
If part-time, how many hours per week?
Work ScheduleFT, 40 hours per week
Proposed Start Date
Estimated Duration of Appointment 6 months not to exceed 11 months
Posting Open Date 08/05/2021
Posting Close Date 08/25/2021
Description of WorkThe Regulatory Assistant is responsible for regulatory compliance of clinical trials performed by the assigned disease group providing para-professional support. The position requires that the person be responsible maintaining regulatory documents including 1572s, Delegation of Authority, and most current versions of all protocol documents. The assistant works with all study team members to provide documents needed for monitoring and auditing of studies.

• Ensure quality in the maintenance of regulatory files

• Upload study documents for monitor visits and audits

• Submit regulatory documents to external sponsors prior to the Site Initiation Visit

• Collect all applicable regulatory documents and training for new study personnel within specified timeframe

• Collection

• Maintain IRB approval of assigned trials, new protocol submissions, amendments and other regulatory actions

• Prepare studies for termination and pull files for archiving

• “Dock” or upload documents into OnCore in required timeframe to include revised consents, changes in protocols and staff additions

• Support Pod Meetings by providing training and documentation on protocol changes. Take minutes.

Education and ExperienceBS Degree; or equivalent combination of training and experience

• Technology skills- Office 365, 2016, TEAMS

• Electronic Regulatory system & OnCore database

• Ability to handle multiple projects simultaneously

• Possess a high level of organization and attention to detail

• Excellent communication skills

• Ability to learn and understand new technology

• Administrative experience

• Working with investigators

• Knowledge of clinical research practices

• Knowledge of FDA submission process

Preferred:

• Knowledge of regulatory policy relating to IRBs

• Clinical research

• Oncology

Special Physical and Mental Requirements
Equal Opportunity Employer StatementThe University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
Stimulus/ARRA Funded No
Special InstructionsUNC-Chapel Hill and NC State University are collaborating to extend NC State’s internal temporary staffing function as a shared service for both institutions. Under this partnership, UTS provides exclusive temporary staffing services to UNC-Chapel Hill and NC State, employing candidates to work as temporary employees in a variety of jobs on both campuses. If interested, please apply here: https://jobs.ncsu.edu/postings/146203
Temporary Employment Policieshttp://hr.unc.edu/policies-procedures-systems/spa-employee-policies/temporary-employment/relevant-policy-information-for-temporary-employees/
Quick Link https://unc.peopleadmin.com/postings/197091
Office of Human Resources