Regulatory Associate

Job Description

Description

Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve.

Summary:
The primary purpose of this position is to ensure our site’s compliance in conducting clinical research in all our facilities.

Responsibilities:
1. Independently administer regulatory compliance for assigned studies, applying full knowledge of Good Clinical Practice (GCP) and the federal regulations governing clinical research in the United States.
2. Take responsibility for IRB submissions and modifications (accurate & timely preparation for initial reviews, amendments, annual renewals and ad hoc submissions).
3. Provide appropriate training and compliance guidance to our investigators, research staff and other key personnel during our study start up meetings and during the ongoing conduct of each research study.
4.    Lead multiple concurrent study projects and negotiate sharing of work within the regulatory team to accomplish research objectives. Schedule and direct activities effectively; make changes to workflow and assignments in consultation with research manager.
5.    Lead exchange of information with sponsors, auditors, investigators and IRBs; collaborate as needed to resolve key regulatory issues efficiently.
6.    Conduct root cause analysis in collaboration with research manager to determine course of events leading to any protocol deficiency/deviation/violation.  Guide staff in proper documentation of clarifying notes for study specific regulatory files and develop written corrective and preventive actions (CAPAs) as required.
7.    Maintain essential documents for all investigators and study files. Ensure all key personnel have documented training for each study.   Take responsibility for maintaining each study’s delegation of authority and training log documents.
8.    Create and maintain professional working relationships with investigators, sponsors, team members, IRB personnel.
9.    Provide consultation and guidance to our Regulatory Specialist on IRB processes, implementation of IRB actions and regulatory compliance.
10.    Write comprehensive reports that convey meaning effectively.
11.    Lead all audit preparations for our regulatory team.  Be prepared to speak authoritatively during any scheduled or unscheduled audit.

Other Information

Other information:
Education Requirements:
● Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience. Master’s degree or higher preferred.
Licensure/Certification Requirements:
● CCRP, CCRC, CIRB, or RAC Certification Preferred.
Professional Experience Requirements:
● At least one year of experience in clinical research required.
Knowledge/Skills/and Abilities Requirements:
● Significant Use of Information Technology is expected for this position
● Excellent technical writing skills
● High degree of accuracy is required for this position
● A high degree of attention to detail and concentration are required for this position.
● Manipulative skills are those required to use standard office equipment, including computers.

Job Details

Legal Employer: NCHEALTH

Entity: UNC REX Healthcare

Organization Unit: Rex Cancer Center Research

Work Type: Full Time

Standard Hours Per Week: 40.00

Salary Range: $25.94 - $37.29 per hour (Hiring Range)

Pay offers are determined by experience and internal equity

Work Assignment Type: Hybrid

Work Schedule: Day Job

Location of Job: US:NC:Raleigh

Exempt From Overtime: Exempt: Yes

This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Heath Care System. This is not a State employed position.

Qualified applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities. All interested applicants are invited to apply for career opportunities. Please email [email protected] if you need a reasonable accommodation to search and/or to apply for a career opportunity.