PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
JOB SUMMARY This is a position that assists to ensure compliance by clinical researchers with federal regulations for the protection of human subjects participating in research. This position administers and coordinates the day to day management of the OhioHealth Research Committees and the OhioHealth Institutional Review Boards.
RESPONSIBILITIES AND DUTIES
Works closely with the Research Committee Chairs, Institutional Review Board Chairs, Human Research Protections Manager to provide administrative support and regulatory expertise in the review and processing of new and ongoing research submissions
Conducts initial review of protocol submissions, including review of required materials, application responses, signatures and institutional requirements to ensure human subjects research protection training and conflict of interest have been met
Provides timely and accurate guidance to Investigators and/or Research Support Staff on preparation and submission of protocol submissions; Works with researchers to adjust study documents to meet regulatory requirements and local standards prior to Research Committee review in order to ensure the committee members receive sufficient information to provide adequate review of proposed and ongoing research and to make the appropriate regulatory determination necessary for approval
Coordinates the protocol review process; outlines regulatory issues that require committee reviewers attentions, provides regulatory guidance to reviewers, and consults the Human Research Protections manager for guidance and mentorship when requirements are unclear
Makes determinations of eligibility for expedited review or exemption from IRB review requirements, based on criteria defined federal in regulations
Makes determinations of institutional engagement and assists with executing interinstitutional agreements to assure adequate institutional oversight for the protection of human subjects participating in research, screens industry studies reviewed by a central IRB to ensure adequate management of educational requirements and resolution of any financial conflicts of interest prior to review by a central IRB
Organizes, coordinates and attends monthly meetings of the Research Committees and Institutional Review Boards; including scheduling and catering service as necessary, building agendas, taking meeting minutes that document regulatory findings as required by HHS and FDA to assure institutional compliance in the protection of human subjects; Assists the Human Subjects Protections Manager with regulatory and policy training for committee members; Distributes protocol materials, regulatory and policy background, and any corresponding guidance documents to all committee members for review via electronic IRB submission system prior to meeting; Assigns Research Committee reviewers and IRB members to lead Committee discussions of the protocol; Notifies Investigators and/or Research Support Staff, in a timely manner, of committee decisions and requested corrections/changes
Obtains corrections from Investigators and/or Research Support Staff as necessary, including, if necessary, assisting researchers with rewriting or revising informed consent forms so human research subjects are provided with information in layman's terms
Coordinates continuing reviews of all ongoing research to determine continued compliance with regulations. Solicits requests for reports from Investigators and/or Research Support Staff. If appropriate, requests additional information from Investigators and/or Research Support Staff before Research Committee review
Advises and distributes guidance documents to Investigators and/or Research Support Staff on institutional policies/guidelines and federal regulations governing the protection of human subjects in research
Assists with editorial review, revisions, implementation and maintenance of IRB forms, meeting minutes and all necessary records according to FDA and HHS and other appropriate regulatory agencies compliance requirements; and Works with Human Research Protections Manager to continuously expand upon the body of knowledge and ability to apply the federal, state, local, and institutional regulations governing human research protection program policies to ensure regulatory compliance and the robust protection of human subjects.
INFORMATION SECURITY Maintains confidentiality of log-on password(s) and security of other authentication devices (e.g., key fobs, proximity devices, etc.). Ensures privacy and security of information entrusted to their care. Uses company business assets and information resources for management-approved purposes only. Adheres to all information privacy and security policies, procedures, standards, and guidelines. Promptly reports information security incidents to the OhioHealth Information Security Officer.
PHYSICAL DEMANDS AND WORK ENVIRONMENT While performing the duties of this job, the employee is frequently required to sit; stand, use hands, stand reach, talk and lift items under 50 lbs. The employee must occasionally lift and/or move up to 50 pounds. Specific Vision abilities required by this job include close, far and colored Vision. Work environment: The noise level in the Work environment: is usually quiet.
OSHA BLOOD BORN PATHOGENS EXPOSURE No Exposure
Additional Job Description
Degree with 1- 3 years relevant Experience . Excellent computer skills and the ability to quickly learn new software programs with minimal training or oversight; familiarity with the FDA and HHS regulations governing human research protections, a good working knowledge of the scientific method and associated principles, familiarity with the IRB review process, and fluency in medical terminology. Demonstrates a high level of customer service, reliability, responsibility, organizational skills with deadline driven projects.
MINIMUM QUALIFICATIONS Bachelor's Degree Field of Study: Business Years of experience: 1 to 3
SPECIALIZED KNOWLEDGE Degree with 1- 3 years relevant Experience. Excellent computer skills and the ability to quickly learn new software programs with minimal training or oversight; familiarity with the FDA and HHS regulations governing human research protections, a good working knowledge of the scientific method and associated principles, familiarity with the IRB review process, and fluency in medical terminology. Demonstrates a high level of customer service, reliability, responsibility, organizational skills with deadline driven projects.
DESIRED ATTRIBUTES Experience in reviewing and editing clinical research proposals and applying federal rules and regulations, including but not limited to 45 CFR 46, 45 CFR 160, 45 CFR 162,45 CFR 164, 21 CFR 50, 21 CFR 56, 21 CFR 312, and 21 CFR 812. Experience with IRB administration, education and training. Advanced analytical skills. Experience in working with a research scientific review committee. Certified IRB Professional (CIP) or a willingness to become certified within two years of employment.
Internal Number: JR11823
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We are a unique organization in the healthcare field. Our model system of facilities encompasses a wide scope of expertise and care. For professionals, we are a place where people committed to doing their best are given the tools and resources to accomplish our mission every single day.
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... if your passion is to work in a caring environment
... if you believe that learning is a life-long process
... if you strive for excellence and want to be among the best in the healthcare industry
Equal Employment Opportunity
OhioHealth is an equal opportunity employer and full...y supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment