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Duke University Job Description

QA & REGULATORY COMPLIANCE ASSOC

Job Code: 2766
FLSA: E
Job Level: 14
Revised Date: 12/01/2007
Job Family: JF 05

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Occupational Summary

Develop, implement and oversee quality assurance and regulatory compliance strategies of the School of Medicine.

Work Performed

Develop, implement and oversee quality assurance and regulatory compliance strategies of the School of Medicine; monitoring and auditing of clinical trials.

Initiate development of standard operating procedures for monitoring and auditing of clinical trials.

Ensure trials are consistent with proposals approved by the Institutional Review Board, and in compliance with applicable federal and state laws, statutes and regulations Lead the design of monitoring programs to ensure human and animal safety.

Identify training and educational needs regarding clinical and manufacturing practices and make recommendations.

Develop and monitor programs to ensure compliance with (Health Insurance Portability and Accountability Act) HIPAA regulations.

Identify and rank areas at risk of exposure to Compliance Officer and recommend strategies to address such issues.

Develop systems and relationships to support auditing acitivity in collaboration with the compliance officer; organize panels of experts to asssit in reviews and analysis.

Identify and report general compliance issues that may arise through the work process; write and revise standard operating procedures.

Review technical publications, articles and abstracts to stay abreast of current regulations and trends, ensure appropriate actions are taken to incorporate necessary revision into workplace environment.

Collaborate with and advise the institutional conflicts of interest committee on management plans.

Serve as liaison to other institutional monitoring and audit groups.

Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

 

Required Qualifications at this Level

Education/Training:

Work generally requires a bachelor?s degree in a biological Science.

 

Experience:

Work requires six years of experience quality assurance or quality control related to clinical trials.

A Master?s degree in a related field may be substituted for 2 years of required experience.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

 

Skills:

N/A

 

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.


Essential Physical Job Functions

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.