About inVentiv Health Clinical:
inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team. With 7,000 passionate employees in more than 36 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. inVentiv Health Clinical is part of inVentiv Health, a best-in-class team of global healthcare experts offering clinical, commercial and consulting services designed to provide a comprehensive customer experience that delivers greater long term value.
The Sr. Quality Assurance Auditor will conduct routine, focused and directed audits of human subject research protocols to ensure compliance with federal/local regulations/guidelines and research site specific SOPs. The incumbent on this position will advise appropriate institutional officials of deficiencies and will also recommend necessary corrective actions with follow up to ensure that needed actions have been implemented.
Accountabilities (For Non-exempt Employees Include Percent of Effort):
- Conducts routine, focused and directed audits of human subject research protocols to ensure compliance with federal and local regulations and guidelines and research site specific SOPs.
- Advises appropriate institutional officials of deficiencies and recommends necessary corrective actions, with follow up to ensure that needed actions have been implemented.
- To remain in compliance with federal, state, and local regulations and/or extramural agencies' requirements or as requested by the Institutional Official, investigates and/or conducts inquiries of laboratories and research protocols.
- Prepares reports of investigations/inquiries for internal and/or external use.
- Assists Director in the preparation and presentation of educational programs to groups and individuals in the University research community.
- Assists in or conducts the preparation of research teams for FDA or other regulatory agency audits.
- Assists research teams with required written responses to observations resulting from audits conducted by regulatory agencies.
- Assists in the training of QA Auditors.
- Monitors new legislation or changes in regulations that might affect the University's compliance in conducting research, recommending changes to administrative policies and procedures, as appropriate.
- Interacts with appropriate persons/agencies (e.g., Offices of Environmental Health and Safety, Human Subjects Research Office, HIPAA Office, Billing Compliance, etc.) to resolve research-related compliance problems.
- Assists Director in the creation and maintenance of internal policies and SOPs as well as University-wide policies intended to assist University researchers in maintaining compliance with research standards and guidelines.
- Maintains RSQA related databases and electronic and paper audit files
- Other duties as assigned.
- Bachelor's degree in science, health care, or related field; Master’s preferred
- A minimum of three years of effective work-related research experience, including research compliance or study coordination and GCP auditing experience.
- High-level interpersonal skills are required.
- Excellent English oral and written communication skills and strong computer skills are required.
- Professional certification in at least one of the following areas: clinical research, research compliance, auditing, GCP-related field, etc. is preferred.