Director of Compliance

The Director of Compliance (DC) is a leadership position reporting directly to Test Facility Management of East Tennessee Clinical Research, Inc. (ETCR) and serves as a member of the Quality Assurance Unit.  The primary function of the DC is to assure management that the facilities, equipment, personnel, methods, practices, records, and controls satisfy the appropriate regulatory standards.  He/she serves as a resource for ETCR staff regarding issues of compliance and protocol awareness.  The DC reviews protocols in conjunction with the Scientific Officer and Trial Coordinator and anticipates potential problems related to compliance in conducting the study and in the documentation of trial activities.  He/she inspects certain critical phases of studies and records the inspection findings.  The incumbent audits the study files and data records, in conjunction with Quality Control personnel, to assure the quality, integrity, and completeness of data.   The DC assists with inspections from external agencies and responds to audits in a timely manner.  The Director of Compliance provides Quality Assurance compliance statements as indicated, reflecting inspections and audits of trial activities and data. 
Position Accountabilities and Performance Criteria

1. Serves as a resource person to ETCR staff for compliance with federal regulations, the Animal Welfare Act, study protocols, facility Standard Operating Procedures, and any other regulated activities. 
2. Oversees inspection of equipment to assure that maintenance and calibration meet the required regulations. 
3. Oversees inspection of facilities to assure that form and function meet the specification of the relevant study protocol.
4. Facilitates completion of all paperwork associated with new employee orientation.
5. Inspects personnel training files to assist mangers with employee training and updating employee resumes and training files.
6. Provides updated training for ETCR staff on GLP and GCP guidelines, and ETCR SOPs; provides similar training to new employees.  
7. Coordinates, updates and facilitates the review of ETCR SOPs in conjunction with the appropriate ETCR staff.
8. Coordinates domestic and international shipments according to the specifications of the receiving lab or Protocol as applicable.
9. Audits Standard Operating Procedures for completeness and deviations from current practices.
10. Creates Adobe documents of fully executed SOPs and maintains a Master SOP Schedule.
11. Reviews study protocols in conjunction with the Scientific Officer and Trial Coordinator to anticipate any compliance issues.
12. Maintains copies of protocols and updates the Master Schedule of (GLP) studies.
13. Conducts inspections of critical phases of trials and generates audit reports based on findings.  The audit reports are submitted to the appropriate parties in a timely fashion.
14. Oversees auditing of all raw data in the study file by Quality Control personnel; identifies corrections to be made and ensures completion of the corrections by ETCR personnel prior to submitting the file to the sponsor.
15. Responds to external audit reports and assists ETCR staff to make identified corrections in a timely fashion.
16. Audits Final Study Reports to assure that the report accurately and completely describes the methods used, SOPs utilized, major study findings, and that the applicable regulatory requirements were met.
17. Audits the receipt, storage, and reconciliation of the test article.
18. Provides Quality Assurance compliance statements reflecting inspections of critical study events and audits of data as indicated.
19. Respects the confidentiality of study information: uses discretion in discussing study information, secures study notebooks in locked cabinets and stores all pertinent archival data in the Secure Records Storage area.
20. Participates in national organizations (e.g., Society for Quality Assurance) and attends regional meeting to increase knowledge and expand contacts within the Q.A. specialty. 
21. Demonstrates independent work skills and shows initiative in completing assigned tasks in a timely manner.
22. Maintains a good working relationship with all ETCR staff.

Position Qualifications
    Minimum Education                                                                                Possession of a Bachelor's degree or                                                                                                                       experience in a related field is preferred.
    Work Direction                                                                                        Reports directly to, and takes direction                                                                                                                       from, the Test Facility Management.