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QA AUDIT COORD
Job Title: QA AUDIT COORD
Job Code: 1828
Job Level: 11
Revised Date: 07/01/2017
Job Family: JF 05
Conduct internal quality audits and process inspections of clinical trials to ensure compliance with applicable regulatory requirements and standard operating procedures.
Lead the Document Management Support Team (DMST) by planning, coordinating, and assigning audit logistics. Provide Pre and Post Audit support to Lead Audit Facilitator(s) by coordinating activities of staff, compiling documentation, and acting as liaison between audit team and DCRI staff during sponsor audits and regulatory inspections.
Co-facilitate and represent the DCRI during audits conducted by external organizations including sponsors and regulatory authorities. Serve as Quality System Document (QSD) coordinator to ensure auditors/sponsors are confident on the DCRI QSD Quality Compliance Management Program. Create, Maintain and distribute the QA/RC DCRI briefing manuals for sponsor audits.
QUALITY SYSTEM DOCUMENTS (QSDs)
QSD Coordinator for all DCRI Quality System Documents (QSDs). Responsible for maintenance of document control system. This includes consultation, reviews, tracking, edits/formatting, spelling, clarity, follow-up, coordination of procedural documents effective dates, LMS Training posting/notification, DCRI intranet posting (SharePoint PULSE), maintaining original paper, current, archived and retrieval of electronic files; all-inclusive parts of managing the QSDs.
DCRI QA/RC QSD Coordinator: provide consultation to DCRI personnel on all DCRI Quality System Documents (policies, SOPs, work instructions, guidelines, forms and templates), Planned and Non-Planned Deviations, QA/RC senior management reports. Maintain QSD process instructions for updating and posting documents.
Main point of contact for the DCRI Quality System Documents (QSDs), Planned and Non-Planned Deviations. Coordinate the revision process from draft to authorization of approval.
Monitor, assess and manage Planned Deviations and Non-Planned Deviations for all DCRI QSDs. Collaborate with DCRI staff on Planned Deviation validity based on QSD justification provided by requestor.
Post all QSDs for DCRI functional groups (FGs) on DCRI Intranet Share Point (Pulse). Manage DCRI QA/RC organizational charts, QSD TOCs and training matrices on Pulse.
Collaborate with DCRI Organizational Learning Consultant on posting and reporting QSD Training for all FGs in the Duke Learning Management System (LMS).
Distribute QSDs to sponsors as requested by DCRI Leadership. Assist FGs in development of corrective action plans for bringing QSDs to compliance. Track, compile, prepare and present QSD Metrics (status/trends) to management. Provide monthly QSD Reports to each DCRI FG.
Ensure all DCRI QSDs meet regulatory requirements, demonstrate good documentation practices, and are stored in a manner that can be retrieved quickly and efficiently when needed during daily operations, audits or inspections.
Provide support and guidance to DCRI staff on Quality System Document issues.
Prepare and communicate DCRI-wide training for QSD required training.
Maintain QSD Archival System to ensure accurate storage of Quality System Documents (QSDs).
Track and communicate review, approval and follow-up with each FG to complete their QSD Reviews to meet timeline requirements.
Notify management of significant and/or serious compliance concerns, deviations and mitigate strategies.
Participation in transition of all QSDs to electronic platform.
Contribute and assist in development and review of all QSDs for QA/RC.
Maintain, track and analyze the training database for QA/RC staff training files and training matrix (CITI, Duke, LMS, and DCRI Requirements). Ensure files content are current, appropriately filed, and accurate. Communicate training requirements to ensure QA/RC staff are compliant.
Collaborate with Organizational Learning on training reports, assist QA/RC staff on training related issues. Liaison to Organizational Learning (OL) FG.
Develop, review, maintain and communicate DCRI Training Matrices for the QA/RC FG.
Monitor and coordinate resolutions for the DCRI QA/RC email account and the telephone contact number.
Assist and provide back-up to the QA/RC Audit Coordinator.
Required Qualifications at this Level
Work generally requires a bachelor's degree in an analytical field.
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
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.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
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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.