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Job Summary:

The IRB Coordinator maintains comprehensive and up-to-date knowledge of human subject research protections and IRB operations including new or revised regulations and guidance issued by the Office of Human Research Protections (OHRP), the Food and Drug administration (FDA), the Commonwealth of Virginia, and other regulatory agencies as applicable Communicates with Principal Investigator and research staff to ensure that all IRB submissions documents are complete and accurate for MWH IRB review. This position works closely with IRB stakeholders.

Essential Functions & Responsibilities:Serves as a subject matter expert by educating, consulting, and guiding researchers in the design and conduct of human subject research to ensure compliance with federal and state regulations and MWHC policy. Advises research personnel in preparing research protocols and subsequent submissions for IRB review.
Educates and guide IRB members on the federal and state regulations and MWHC policies governing human subject research.
Develops and implements education sessions on topics related to human subject research protections to MWHC researchers and IRB members.
Pre-reviews research protocol submissions to ensure that individual research protocols involving human subjects comply with federal regulations, state laws and MWHC policies and procedures for conducting research. Independently conducts and documents. administrative and regulatory reviews within the context delegated by the IRB chair.
Composes letters that accurately communicate and document the determinations, describing any/all revisions required by the Principal Investigator in order to secure IRB approval.
Maintains IRB-required record keeping and prepares correspondence to investigators, study sponsors, and regulatory agencies that document the determinations of the IRB.
Prepares IRB meeting agendas and meeting materials for distribution to IRB members. Assist the IRB Chair in facilitating the conduct of convened IRB meetings.
Participates in the development, revision, and implementation of MWHC policies and procedures, and IRB forms.
Ensures continued compliance with federal regulations, state laws, and MWHC policies. 
Addresses any compliance issues and actively works to resolve concerns.
Performs other duties as assigned.

Qualifications:

Bachelor’s Degree, preferred
A minimum of 1 year of IRB, clinical research, or other related experience.  
Strong knowledge of FDA regulations and ICH GCP guidelines required.
Medical terminology preferred.
Excellent interpersonal, organizational, detail oriented and problem-solving skills.  
Working knowledge of computer systems and desktop office applications required and ability to adapt to new software applications.  
Demonstrates proficiency in verbal and written communication required and to make decisions independently as appropriate. 

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, color, religion, sex, sexual orientation, gender identity, national origin, and veteran or disability status.