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Regulatory Specialist

Job ID: 11723
Location: Chapel Hill, NC
Facility/Division: Shared Services
Status: Full Time
Shift: Day Job

Did you know UNC Health has Ranked #2 Most Trusted Healthcare Brand in the U.S.? The UNC Health brand was ranked as the #4 healthcare brand in the United States overall and the #2 most trusted healthcare brand, just after Johns Hopkins and before Mass General. Join our One-Great-Team!

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:
Responsible for regulatory compliance for research studies conducted at the Hospital.

Responsibilities:

1. Maintains an environment of safety for patients, self and others.
2. Maintain complete regulatory files for each protocol.
3. Submit protocol for approval following IRB policies and procedures.
4. Verify that the written informed consent document includes the basic elements of informed consent. Submit informed consent document and HIPAA authorization to IRB following IRB policies and procedures.
5. Submit protocol amendments, informed consent and HIPAA revisions to the IRB following IRB policies and procedures.
6. Verify that the subject received a copy of the signed and dated written informed consent document and document is in the medical record.
7. Prepare written summaries of the study's status for the IRB on an annual basis for study renewal following the IRB policies and procedures.
8. Participate in sponsor audits/review of records and documents
9. Participate in regulatory inspections of records and document such as FDA.
10. Ensure subject records are protected in accordance with applicable regulatory requirements.
11. Verify compliance with regulatory requirements. Verify date of IRB approval before study initiation. Maintain regulatory compliance throughout the conduct of the study.
12. Submit closure notifications to IRB following IRB policies and procedures.

Other information:

Education Requirements:
● High School diploma or GED
Licensure/Certification Requirements:
Professional Experience Requirements:
● 2 years research related experience
Knowledge/Skills/and Abilities Requirements:
● Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. IT Skills: Ability to work effectively in Word, Excel and various report writing programs. Ability to create reports, analyze data and make sound business decisions based on appropriate information sources. Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Job Details

Legal Employer: NCHEALTH

Entity: Shared Services

Organization Unit: Research Compliance 

Work Type: Full Time

Standard Hours Per Week: 40.00

Work Schedule: Day Job

Location of Job: US:NC:Chapel Hill

Exempt From Overtime: Exempt: No



This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Health Care System, in a department that provides shared services to operations across UNC Health Care. This is not a State employed position.
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Diversity Statement

The UNC Health System and the UNC School of Medicine are committed to valuing all people throughout our organization, regardless of background, lifestyle, and culture. A diverse and inclusive work environment for staff and culturally appropriate care for our patients, are essential to fulfilling our UNC Health vision of improving the health of all North Carolinians.

Equal Employment Opportunity

UNC Health is an equal opportunity employer. As such, UNC Health offers equal employment opportunities to applicants and employees without regard to race, color, religion, sex, national origin, age, genetic information, disability, sexual orientation, gender identity or political affiliation.

To verify employment eligibility, UNC Health is committed to Form I-9 and the E-Verify process. Learn further E-Verify details in English or Spanish.

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