Supports client's Human Research Protections Office to protect the rights and welfare of human research subjects in compliance with all applicable law, regulations, policies, procedures, and ethical guidelines related to the protection of human subjects in research. Administrative: Coordinates administrative functions related to IRB review of submissions. Education: Maintains expertise in compliance issues and promotes continuing education for investigators, IRB members and staff, and institutional officials.
??? The IRB Coordinator supports the lnova Human Research research subjects.
??? The Coordinator will be responsible for research experience conducting a regulatory review of IRB submissions projects submitted for lRB review.
??? The individual will oversee the accurate and timely processing, tracking, and filing of submissions related to human subject research. He/she will communicate effectively with investigators, sponsors, and IRB members.
??? The IRB Coordinator will maintain an accurate and comprehensive database of reviewed research, as well as maintaining communications with investigators, regulatory entities, and any others involved in the conduct of submitted research.
??? The individual will maintain suspensions, administrative closures. and final reports for the IRBs.
??? The IRB Coordinator triages research submissions for not-human-subject determinations, exempt, expedited or convened IRB review.
??? The individual ensures investigators are aware of due dates for submission of renewals and other required reports.
??? He/she certifies that information submitted by investigators is adequate for effective HRPO and IRB review, advising investigators in the preparation of their applications and accompanying materials.
??? The individual will provide regulatory guidance to the IRB members related to human subject research to ensure research is reviewed in compliance with institutional policies, State and Federal regulations pertaining to research as well as ICH, GCP and
??? HJPAA. This list of duties and responsibilities is not intended to be all- inclusive and may be expanded to include other duties or responsibilities as necessary.
Working hours: 8:00 AM - 5:00 PM
??? Minimum 3 years of relevant experience
??? Previous IRB/HRPP or clinical research experience a plus
??? Bachelors Degree in relevant MAIMS field required
??? Healthcare or (or equivalent) legal licensure or experience preferred.
??? Expert skills in computerized research database administration, manipulation and analysis. Ability to learn new electronic submission management systems for IRB submissions
??? Certified IRB Professional required within one year of hire
??? Ability to work independently with minimal supervision and/or in a collaborative environment; Possess excellent written and oral communication skills
??? Knowledge of the applicable federal regulations related to human subject research, ICH, GCP and HIPAA.
??? Proficiency in Microsoft Office suite i.e, WORD, Excel, Powerpoint, etc.
??? Previous electronic submission system experience preferred
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