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Job Title: Director, Office for Protection of Human Research Subjects
Company Name: ETSU Office of Research & Sponsored Programs
Location: Johnson City, TN United States
Position Type: Full Time
Post Date: 01/17/2019
Expire Date: 03/17/2019
Job Categories: Research & Development
Job Description
Director, Office for Protection of Human Research Subjects
East Tennessee State University (ETSU) seeks applications and nominations for the position of Director, Office for Protection of Human Research Subjects.

Located in northeast Tennessee's Appalachian Mountains, ETSU is a growing state­supported institution serving over 14,500 students, including more than 2400 graduate students.

Director of the Office for Protection of Human Research Subjects is responsible to the Vice-Provost for Research and Sponsored Programs for supervising the coordinators of the Institutional Review Boards (I RBs) 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.

ETSU has two IRBs with more than 600 active studies. The Campus IRB primarily reviews social science studies submitted by faculty, staff and students at ETSU. The Medical IRB primarily reviews clinically oriented studies submitted by faculty, staff and students in the ETSU health science focused colleges, including: Quillen College of Medicine, Gatton College of Pharmacy, College of Public Health, College of Nursing and College of Clinical and Rehabilitative Health Sciences. In addition, the ETSU Medical IRB serves as the IRB of record for the James H. Quillen Veterans Administration Medical Center and the the Legacy Mountain States Health Alliance (MSHA), now affiliated with Ballad Health.

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 ETSUNA 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 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
• 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; 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.
• 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 Director of Research - Legacy MSHA/Ballad in order to keep individual Ballad 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 of federal policies concerning Human Research Subjects Protection. Knowledge of university and VA policies regarding Human Subjects Research Protection.
Knowledge of medical terminology
Ability to interpret and apply institutional and federal policies, procedures and
regulations, and to make recommendations for correction 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 Protection
Ability to work collaboratively with regional health care systems
Ability to communicate effectively with various constituents and to motivate individuals.
Ability to maintain confidentiality of information.
Ability to work with computer applications.

Application Review Date: March 1st, 2019
Preferred Start Date: May 1st, 2019
Qualifications & Requirements
Bachelor's degree and at least one year's experience working with a medical IRB, or Compliance and/or clinical trials coordination required Advanced skill with Microsoft Applications which may include Outlook, Word, Excel or PowerPoint and other web-based applications. Demonstrated excellent knowledge of federal regulations pertaining to research on human subjects.

PREFERRED
Bachelor's degree in the biomedical or health related fields, nursing or social sciences or a master's degree preferred; experience in working with healthcare systems preferred.
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Contact Information
Contact Name:Christine Skalko
Company Name: ETSU Office of Research & Sponsored Programs
Contact Email:skalkoc@etsu.edu
Website:https://jobs.etsu.edu/postings/8365
Company Description:
East Tennessee State University (ETSU) is a regional state-supported institution serving approximately 13,400 students yearly, and is located in a beautiful, prosperous, Southern Appalachian Mountain community. The northeast corner of Tennessee, which surrounds Johnson City is metropolitan in population but provides a friendly, small town atmosphere. The area abounds in scenic beauty and in places of historical interest. East Tennessee State University is an AA/EEO employer and does not discriminate on the basis of race, color, national origin, sex, disability, or age in its programs and activities.
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