IRB Specialist I, Center for Clinical Research (Hybrid)
Cleveland, Ohio, United States · Hybrid
Entry level$15M raised
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IRB Specialist I, Center for Clinical Research (Hybrid)
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Full-time
bachelor degree
Posted 9h ago
~40 hrs/week
Responsibilities
The IRB Specialist evaluates human research protocol submissions to ensure compliance with federal, state, and institutional regulations. They also coordinate IRB meetings, manage documentation, and serve as a liaison between committees, investigators, and research staff.
Requirements
Candidates must hold a bachelor's degree in health sciences, bioethics, or a related field and possess at least one year of experience in research or regulatory affairs. Proficiency in MS Office, strong organizational skills, and the ability to obtain CITI certification within 30 days are required.
Full job description
A Brief Overview
The IRB Specialist serves at the crossroads of virtually all activity that occurs in the Clinical Research Center and is therefore a key position in this office. The major functions of the position include evaluating protocol submissions, advising investigators, supporting the IRBs and managing daily operations of the IRB Administration Office.
What You Will Do
Works to obtain and maintain a current understanding of Federal, State and local laws, regulations and guidelines governing human subject research (15%25)
Reviews human research protocol submissions to ensure that the UHCMC clinical research activities are conducted in compliance with IRB policies, institutional SOPs and international, federal, state, and local rules, regulations and ethical principles regarding the use of human subjects in research. (30%25)
Coordinates IRB meetings including preparation of the agenda and materials in addition to recording medical and ethical issues discussed to ensure accurate documentation of IRB determinations. (25%25)
Functions as a liaison within and between the IRB committees, investigators and their designees, and Center for Clinical Research and Technology (CCRT) staff. (15%25)
Participates in special projects. (15%25)
Additional Responsibilities
Performs other duties as assigned.
Complies with all policies and standards.
For specific duties and responsibilities, refer to documentation provided by the department during orientation.
Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Education
Bachelor's Degree in health sciences, bioethics or a related degree (Required)
Work Experience
1+ years prior experience in research, research administration, regulatory affairs clinical and/or laboratory research. (Required) and
Preference given to those candidates possessing IRB experience. (Preferred)
Knowledge, Skills, & Abilities
Knowledge of medical concepts and terminology is helpful (Required proficiency)
Accurate typing skills. (Required proficiency)
Ability to articulate information in grammatically correct written form. (Required proficiency)
Must have excellent organization skills with attention to detail. (Required proficiency)
Works independently as well as in a team setting and meets deadlines. (Required proficiency)
Good attendance record. (Required proficiency)
Service-oriented, self-motivated, professional, discrete, and act with integrity. (Required proficiency)
Prefer knowledge of research regulations, both internal and external. (Preferred proficiency)
Understanding of current NIH, DHHS, OHRP, and FDA guidelines governing human subjects’ research helpful. (Required proficiency)
Ability to perform multiple duties simultaneously and to manage occasional increased workload volumes. (Required proficiency)
Ability to prioritize and process IRB submissions in an expeditious and efficient manner. (Required proficiency)
Proficient in use of PC and all MS Office software (Required proficiency)
Licenses and Certifications
Certification in Human Subjects Protection (CITI) (Required within 30 Days)
Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 23 hospitals (including 5 joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University and the Technion Israel Institute of Technology. The main campus also includes the UH Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees.
Offices: University Hospitals, 11100 Euclid Avenue, Cleveland, Ohio 44106, US · 3605 Warrensville Center Rd, Shaker Heights, Ohio 44122, US
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There are currently 105 open legal positions in Cleveland, OH listed on Clera. New openings are added daily as companies post roles.
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Companies currently hiring include Benesch Law, County of Kauaʻi, Kisling, Nestico & Redick, LLC (KNR), Sherwin-Williams, The Freelance Firm, among others. Browse the listings above to see every active employer.
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