UTS-Temporary Regulatory Associate Details

UTS-Temporary Regulatory Associate

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

Employment Type : Full-Time

Position Type Temporary Staff (SHRA)
Job Title UTS-Temporary Regulatory Associate
Department Name HR UTS Partnership
Vacancy ID S018256
Position Posting Category Research Professionals
Hiring Range $26.50-$28.00
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 Associate is responsible for regulatory compliance of clinical trials performed by the assigned disease group. The position requires that the person be responsible for IRB submissions and responses and for creating and maintaining professional working relationships with investigators, sponsors, team members, and others.

• Obtain written and dated approval from the IRB for trial protocols, written informed consent forms and updates, subject recruitment procedures (advertisements) and any other written information to be provided to subjects.

• Provide all documents to the IRB that are subject to review.

• Submit protocol deviations for IRB review according to IRB and Lineberger SOPs.

• Submit written summaries of the trial status to the IRB annually, or more frequently if requested by the IRB.

• Promptly provide written reports to the IRB on any changes significantly affecting the conduct of the trial and/or increasing the risk to subjects.

• Report unexpected serious adverse drug reactions to the IRB according to IRB SOPs.

• Revise written informed consent form and any other written information to be provided to subjects whenever important new information becomes available that may be relevant to the subject’s consent. Obtain IRB approval prior to distributing for use with subjects.

• Prepare for monitoring and audit by the sponsor and inspection by appropriate regulatory authorities. Meet with sponsor representatives and inspectors. Provide information at time of visit and follow up on actions identified in monitor and audit reports within 30 days.

• Support trial-related knowledge in assigned disease group by participating in start-up meetings and by organizing and documenting training on amendments.

• Support Pod Meetings by providing documenting information on new study selection and activation, trial and accrual status, and implementation of regulatory functions.

Education and Experience

• BS Degree
• 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

• Preparing consent forms

• Reporting non-compliance

• Working with investigators

• Knowledge of clinical research practices

• Knowledge of FDA submission process

Preferred:

• IRB Submission

• Oncology

• Experience in clinical research including familiarity with CFR Parts 50, 54, 56, 312, 314 and ICH Guidelines.

CCRP, CCRC, CIRB or RAC Certification preferred
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/197093
Office of Human Resources