This position will be responsible for ensuring appropriate Quality and Regulatory Management is applied to all clinical studies conducted by the Duke Vaccine and Trials Unit (DVTU) at the Duke Human Vaccine Institute. The position will develop, implement and oversee quality assurance and regulatory strategies for the DVTU in collaboration with DVTU Investigators, clinical staff and DVTU administrative teams. Quality assurance and regulatory activities will span the life of clinical trials including protocol development, start-up, implementation and close-out. Specific Duties to perform include the following:
Develop, implement and oversee quality assurance and regulatory compliance strategies for the DVTU; monitoring compliance to quality assurance guidelines as governed by Duke University School of Medicine, Duke Office of Clinical Research and applicable sponsors.
Ensure DVTU trials are consistent with proposals approved by the Institutional Review Board, and in compliance with applicable federal and state laws, statutes and regulations.
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research conducted by DVTU. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
Develop and monitor DVTU programs to ensure compliance with (Health Insurance Portability and Accountability Act) HIPAA regulations.
Participate in development of DVTU protocols to assist with internal quality control of protocol and protocol associated documents; ensure all documents are consistent with each other.
Develop and oversee the implementation of Standard Operating Procedures for the DVTU. Evaluate team's suggestions to improve processes and SOPs.
Use system reports to ensure DVTU, division, or department compliance with institutional requirement/policies, including those that are national or international; assist team members with understanding these requirements and policies.
Communicate concerns clearly and in a professional manner. Recognize when others need to be brought into the conversation and escalate appropriately. Work closely with sponsor and study personnel on relevant regulatory and/or safety issues. Take action when communication has stalled with sites, CROs, sponsors, or team members. Act as an expert regulatory resource to junior staff liaising with sponsors, subcontractors, or vendors.
Lead Quality Assurance Activities for DVTU:
Develop and maintain quality assurance plan/s specific to the unit and applicable sponsor requirements.
Develop, or assist with development of, SOPs for data quality assurance. Evaluate team's suggestions to improve processes and SOPs.
Oversee the creation and use of queries, summaries, and reports for quality assurance purposes.
Adhere to established processes and run queries, summaries, and reports to monitor the quality of data.
Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data.
Conduct internal quality assurance audits of regulatory files and assist with third party monitoring visits.
Recognize trends related to data quality and quality of regulatory files and escalate as appropriate.
Identify and rank areas at risk for non-compliance and work to mitigate risks in coordination with the DVTU Investigators, clinical staff and DVTU administrative teams.
Specific Regulatory Activities for the DVTU.
Oversee initial submission of documents such as consent forms, protocols, and participant materials to DUHS Institutional Review Board
Assure timeliness of continuing reviews and study closure to the DUHS Institutional Review Board. Review submission of Adverse Events Reports by study team to assure that reporting to the DUHS Institutional Review Board and sponsors is prompt and meets reporting requirements (timelines and forms).
Serve as a unit resource for development of IRB documents and for guidance on IRB communications.
Collaborate with study team to maintain appropriate study- level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Provide training in these areas. Oversee study teams' maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
Coordinate with sponsors, the submission of regulatory documents at study start-up and close out.
Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings.
Education/Training: Completion of a bachelor's degree in a biological related science
Experience: At least six years of appropriate regulatory/clinical/quality management experience is required. Knowledge of clinical trials guidance documents for the conduct of trials and applicable federal and state laws, statutes and regulations.
Skills: Can easily use computing software and we-based applications (e.g., Microsoft Office products and internet browsers). Experience with Visio , Smartsheet and Microsoft Project preferred.
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.
Work generally requires a bachelor’s degree in a biological Science.
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
Younger than most other prestigious U.S. research universities, Duke University consistently ranks among the top schools in the country. It’s 9,000-acre campus is located in Durham, N.C, a city with vibrant business, sporting, and arts communities. Duke also is active internationally through the Duke-NUS Graduate Medical School in Singapore, Duke Kunshan University in China and numerous research a...nd education programs across the globe. Duke employees are part of a premier organization dedicated to excellence in education, research, and patient care. By working at Duke, employees gain the opportunity and the responsibility to make a real difference in the world. Duke is continuously seeking top talent to help contribute to a legacy of great achievement and even greater promise.