SENIOR REGULATORY COMPLIANCE CONSULTANT, DCRI - QA/RC


diversity employer



SENIOR REGULATORY COMPLIANCE CONSULTANT, DCRI - QA/RC
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

The Senior Regulatory Compliance Consultant is responsible for performing a variety of activities involved in assuring compliance with regulatory requirements by conducting investigations and audits, developing and providing GCP training and assisting with the creation of quality policy initiatives. The primary focus of this position is to provide quality and regulatory compliance subject matter expertise to the DCRI.

Work Performed

• Conduct special investigations of high risk compliance/quality concerns in order to develop effective and practical mitigation strategies within the DCRI.

• Serve as senior subject matter expert on Quality Assurance & Regulatory Compliance in order to provide the leadership of the DCRI with cogent and well-ordered information for use in the development of quality systems policy.

• Review and approve QA/RC associates' audit plans and reports with particular regard to sound regulatory compliance and adherence to DCRI quality standards.

• Promote ongoing professional development of all QA/RC associates and serve as a mentor to new hires.

• Assist the Director of QAIRC to afford the DCRI Executive Quality Council with current, accurate and efficient information for the creation of pertinent, economic and effective quality policy initiatives

• Provide expert input to BD regarding resourcing and budget requirements for new bids. Assist with BD presentations regarding QA/RC services.

• Conduct internal and external audits for GCP compliance, prepare reports and review and approve corrective action plans. Facilitate sponsor audits.

• Prepare SOPs, review and approve DCRI SOPS, provide consultation to DCRI personnel in the development of SOPs.

• Develop and provide domestic and international GCP training for both internal and external groups.

• Represent the DCRI in interactions with external organizations such as sponsor. Serve as a point of contact during audits of the DCRI. Act on behalf of the Director, QA/RC in times of absence regarding interactions with the FDA.

• Assist the Director, QA/RC in the on-ongoing Duke University GCP compliance effort.



Requisition Number
401220723

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2861 SENIOR REGULATORY COMPLIANCE CONSULTANT

Job Family Level
16

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Education and Experience:

Master's Degree in Life Sciences, Public Health, Clinical Research or related field. Experience: Minimum of 8 years experience in clinical research, the pharmaceutical, medical device, biotechnical or contract research industry, including a minimum of 4 years experience in Quality Assurance and/or Regulatory Compliance. Academic research and professional leadership experience preferred.

Strong written and oral communication skills required.

Prefer certification or accreditation by Regulatory Affairs Professionals (RAPS), Society of Quality Assurance (SQA), American Society for Quality (ASQ) or similar. Reports to: Director, Quality Assurance and Regulatory Compliance

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 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

86703BR

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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