QA AUDIT COORDINATOR, QA & Regulatory Compliance


diversity employer



QA AUDIT COORDINATOR, QA & Regulatory Compliance
Quality Assurance & Regulatory Complianc

Who We Are:
As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.

Occupational Summary
Coordinate audits and inspections included in the Quality Audit Plan.

Work Performed
-Manage the planning and scheduling of quality assurance audits including internal, sponsor,vendor, site audits.

-Oversee the administrative support for audits including: vendor consultant setup, invoicing and payments,related audit logistics and documentation to support the Quality Audit Plan.

-Assist with monitoring for timeliness of completion for audit related documents by QA/RC Associates and Senior Regulatory Compliance Consultants to ensure that they are in accordance with standard operating procedures at DCRI,by entering related audit data (including data within the Audit and CAPA Reports) and providing trending reports to Management.

-Assist with the conduct of unscheduled regulatory inspections as requested by Management.

-Assist in drafting DCRI SOPs.

-Stay abreast of regulatory, quality, and industry trends (particularly related to GCP, ICH, and NIH requirements) and assists in developing recommendations regarding actions to ongoing compliance.


Requisition Number
401283110

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1828 QA AUDIT COORD

Job Family Level
11

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications


Education

Work generally requires a bachelor's degree in an analytical field.

Experience

Work requires three years of experience in clinical trials, quality assurance, quality control, regulatory compliance or clinical data management to acquire competency in the design, analysis and documentation of clinical trials audits.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

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.

Auto req ID

91406BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

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.

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