The Expedited Reviewer will contribute to the daily activities of the Expedited team. Responsible for expedited review of human subject research using independent judgment and knowledge of regulations to meet and exceed objectives while contributing to the company's overall mission to protect the rights and welfare of human subjects involved in research. This requires knowledge of the federal, state, and international laws, regulations, and guidance, including US Good Clinical Practice (GCP), Code of Federal Regulations (CFR) Titles 21 and 45, and International Conference on Harmonization (ICH) Guidelines. EDUCATION REQUIREMENTS:
Bachelor's degree from a four-year college or university is required. A degree in nursing, biological or chemical sciences is desirable.
CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:
Must commit to passing the CIP exam within 2 years of reaching the minimum qualification of 2 years with an IRB. Maintain CIP certification once obtained
QUALIFICATIONS/EXPERIENCE:
A basic understanding of medical terminology, diseases and their causes, and standard treatments for the more common diseases is preferred.
Three years medical or healthcare related experience is a plus.
Ability to work effectively with diverse groups of people, including but not limited to staff from information technology, clinical backgrounds, materials management, physicians and external vendors.
Excellent attention to detail and creative problem solving abilities.
Proven record of working well under pressure on concurrent, multidisciplinary projects.
Must be willing to learn guidelines and requirements of applicable Regulatory agencies, Federal Drug Administration (FDA) and the Office for Human Research Protections (OHRP).
Ability to read and interpret complex technical documents such as research protocols, consent forms and drug summary information, Federal Regulations and Guidelines, and SOP's.
Self-motivated and assumes ownership of and accountability for assignments and responsibilities.
Strong interpersonal/communication skills such as, listening objectively and openly to others' ideas, and contributing to a positive team spirit, speaking effectively in meetings and to clients and other staff
ESSENTIAL DUTIES/RESPONSIBILITIES:
Interpret and apply Federal Regulations, Board Standard Practice Instructions [SPI] and Guidelines in a manner to assure that the Company is in full compliance with all applicable regulations.
Review submitted protocols and requests for changes in research (CIR) to determine if they meet the regulatory requirement for an expedited review.
May approve protocols or CIR, require modification to the protocol or the CIR in order to approve
Will prepare memorandums per guidelines
Perform all duties of a Board member and the duties of an Expedited Reviewer
Ensure that quality and turn-around time (TAT) expectations are met for assigned work.
Deliver customer focused, cost effective and continuously improving products and services.
Provide superior customer service to both internal and external clients with inquiries, issues or needs.
Contribute to expedited team discussions and projects.
Stay abreast of changes in FDA and OHRP regulations and companywide processes so as to be a reliable resource to other staff and clients.
Analyze requests for exemption determinations and provide formal written opinions that proposed projects are exempt from the requirements for IRB review or do not require IRB review.
ABOUT USFor over 50 years, WCG IRB has been at the forefront of protecting the rights and welfare of human research participants during all phases of clinical trials. Recognized as the gold standard of human subject protection, WCG is the trusted partner to over 1,000 institutions in the United States alone, ranging from small community hospitals and research sites to large academic medical centers and universities. Our unparalleled review ensures that human research studies withstand scrutiny around the world.
