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/ Job Search / Regulatory Specialist

Regulatory Specialist

Job ID: 31190
Location: Raleigh, NC
Facility/Division: UNC REX Healthcare
Status: Full Time
Shift: Day Job

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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. Particpate 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

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.