Function of Position

Responsible to the Vice Provost for Research and Sponsored Programs for supervising the coordinators of the Institutional Review Boards (IRBs) to ensure that the procedures and records of the IRB meet all federal requirements and for coordinating administration of federally mandated educational programs related to university policies concerning human subjects protection; planning and conducting compliance audits to determine compliance, efficiency, effectiveness and management of human research records; making recommendations for improved controls and operating procedures to the Vice Provost for Research and the IRBs; performance of other related duties as assigned.

Essential Functions

 

-          Maintains current knowledge of all policies, directives and regulations that apply to research on human subjects.

-          Supervises the IRB Coordinators, secretary and student workers.

-          Assists with continual review of university policies and the application of policies related to federal and state laws and regulations concerning research on human subjects. Develops standing operating procedures appropriately reflective of both ETSU and VA human subject research; prepares/updates policy statements for IRBs and VA R&D Committee approval (reviewed annually).

-          Serves as ex-officio member to the ETSU IRB, the ETSU/VA IRB and the James H. Quillen VA Research and Development (R&D) Committee.

-          Maintains and assures the accuracy of federal and institutional records regarding Human Subjects Research.

-          Coordinates activities necessary to prepare for, achieve and maintain accreditation of the ETSU and VA (affiliate) human research subjects protections program (HRSPP) by the National Committee on Quality Assurance (NCQA) and the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

-          Interacts with researchers to assist in matters of compliance, protocol preparation, problem-solving, and working with clinical trial monitors.

-          Coordinates random audits of records/sites of active and inactive IRB protocols to ensure federal and institutional compliance with directives and mandates concerning informed consent and use of patients in research programs.

-          Serves as advisor to the IRB chairs.

-          Prepares various reports relative to office and IRB activities which are intended for submission to various university and federal offices.

-          Coordinates the administrative requirements of the ETSU HRSPP office and the James H. Quillen VA R&D office.

-          Assures that IRB staff, principal investigators and all key personnel of ETSU, VAMC and MSHA are in compliance with the education standards required by mandate.

-          Maintains security of HSRPP facilities to ensure protection of IRB and research records; oversees allowable access, issuance of keys and maintenance of key files; controls security by regulation of entry codes; maintains liaison with Public Safety and Physical Plant personnel; reviews security practices periodically to ensure continuous protection.

-          Performs analytical and evaluative work associated with program activities; develops procedures and systems for establishing, operating and assessing the effectiveness of compliance control systems and the accomplishment, evaluation, and/or monitoring of audits, inspections, or management or internal control reviews; evaluates results of audits/inspections and forwards action items to the responsible officials.

-          Participates with the Vice Provost for Research and Sponsored Programs in implementing ETSU policies concerning Conflict of Interest and Scientific Misconduct when human subjects protection is involved.

-          Provides staff support in conducting investigations of allegations of scientific misconduct and conflicts of interest that involve human subjects in research.

 

Secondary Functions

 

-          Attends IRB and VA R&D meetings.

-          Reports impact assessment and interfaces with hospital administration to assure investigator compliance with human subject research mandate and institutional policies; provides ongoing management and oversight of the provisions afforded by contractual agreement; assures records access and security; maintains communication with Chief Nursing Officers (CNO) in order to keep individual MSHA facilities appraised of research activity approved for their site.

-          Supports the Quality Assurance Program to evaluate the safety and ethical conduct of the institution and individual researchers.

-          Attends and participates in regional and national meetings as needed to maintain knowledge of regulatory changes and for professional development; collaborates in scholarly activities.

-          Performs other related duties as assigned.

 

Knowledge and Abilities

 

-          Knowledge of federal policies concerning Human Research Subjects Protection.

-          Knowledge of university and VA policies regarding Human Subjects Protection.

-          Knowledge of medical terminology.

-          Ability to interpret and apply institutional and federal policies, procedures and regulations, and to make recommendations for corrective action, if appropriate.

-          Ability to plan effectively and to meet multiple deadlines.

-          Ability to provide effective management of staff

-          Ability to train investigators from any number of research disciplines in principles of Human Research Subjects Protection.

-          Ability to communicate effectively with various constituents and to motivate individuals.

-          Ability to maintain confidentiality of information.

-          Ability to work with computer applications.

 

Supervision Given and Received

 

Performs under general supervision. Determines own methods of performing assigned work. Directly supervises administrative and classified employees.

 

Minimum Qualifications

 

Bachelor's degree in sciences, nursing, social sciences or business required; master's degree preferred; experience in university research administration or compliance and/or clinical trials coordination required; experience in use of computerized information systems.