JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: Under an assigned director, this position manages three related highly complex duties to assist investigator in complying with relevant federal regulations, state laws, and institutional policies related to the conduct of clinical research and in properly documenting compliance with those requirements Ensures the timely reporting of adverse events or other unanticipated problems and address specific concerns identified by the IRB Chair or Director, conduct audits at UTHSC, affiliated institutions, and routine internal audits of the IRB. The three components of this role are: (1) reviewing investigator records, dental/medical records, IRB records; monitoring ongoing research to ensure adherence to study procedures as described in study protocol and informed consent document; observing the consent process; and interviewing investigators, staff and subjects, (2) developing customer satisfaction and needs assessment instruments and analyzing the results in order to identify educational need so the university’s researchers and client institutions regarding regulatory requirements and navigation of IRB application forms and processes, and (3) developing and implementing training programs and materials to meet identified educational needs. Audits and other activities may be conducted at UTHSC and at each of the affiliated institutions.
DUTIES AND RESPONSIBILITIES:
Completes comprehensive reviews of IRB records, investigator study records, and patient medical/dental records when applicable.
Reviews, analyzes, and interprets the application of federal and state laws, regulations, institutional policies and guidelines to protect human subjects and ensures institutional compliance.
Monitors onsite research to determine adequacy of research facilities, studies staff and the protection of human subjects; observes the consent process from initiation to documentation of the subject’s consent, and interviews investigator’s staff and/or subjects.
Provides regulatory, ethical, and method assistance to investigators, staff, and student researchers as applicable to specific audited studies.
Develops customer satisfaction instruments and analyze results; identifies educational needs of researchers based on the results of survey instruments, and develops strategies for meeting those needs.
Identifies protocols to be audited (random/routine and for cause) through review of ongoing clinical trials (enrollment status, risk/benefit ratio, reported adverse events, regulatory issues, etc.); conducts routine internal audits of IRB, including an evaluation of written policies, procedures, databases, file records, and overall efficiency.
Develops and prepares reports when audits are completed and findings are analyzed; assists in the reporting of serious or continuing non-compliance issues to government and institutional official; conducts appropriate follow up to ensure deficiencies are corrected in a timely manner.
Ensures the timely reporting of adverse events or other unanticipated problems and address specific concerns identified by the IRB Chair or Director.
Provides assistance and instruction to Board members, faculty, staff, student researchers and study/research coordinators regarding use of the IRB electronic system and IRB submissions.
Performs other related duties assigned.
EEO/AA Statement /Non-Discrimination Statement
The University of Tennessee is an EEO/AA/Title VI/Title IX/Section 504/ADA/ADEA institution in the provision of its education and employment programs and services. All qualified applicants will receive equal consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity, age, physical or mental disability, or covered veteran status.
Inquiries and charges of violation of Title VI (race, color, national origin), Title IX (sex), Section 504 (disability), ADA (disability), ADEA (age), sexual orientation, or veteran status should be directed to the Office of Equity and Diversity (OED), 920 Madison Avenue, Suite 825, Memphis, Tennessee 38163, telephone 901-448-2112 (V/TTY available). Requests for accommodation of a disability should be directed to the ADA Coordinator at the Office of Equity and Diversity.
EXPERIENCE: Four (4) years professional or business experience (research compliance experience preferred); OR Master’s Degree and two (2) years professional or business experience (Research compliance experience preferred). (Experience with federal regulations for the protection of human subjects preferred).
KNOWLEDGE, SKILLS, AND ABILITIES:
Ability to prepare for and conduct audits or quality assurance.
Ability to write detailed reports.
Ability to develop customer satisfaction instruments and analyze results.
Ability to identify educational needs and develop strategies for meeting those needs.
Ability to analyze and apply ethical codes.
Critical problem solving, analytical, resource management, and creative thinking skills.
Ability to work independently.
Skilled in the use of the computer to include Microsoft Office and survey monkey or other survey instruments (familiarity with data analysis software such as SASS, Strata and/or SPSS is desirable).
Excellent interpersonal, verbal, and written communication skills.