Expedited Reviewer (Remote)

Description and Requirements

• Bachelor’s degree from a four-year college or university is required. A degree in nursing, biological or chemical sciences is desirable

• Commit to obtaining CIP within timeframe specified by management, as aligned with CIP eligibility criteria, exam dates, and business needs. Commonly CIP is expected to be achieved between two and four years of starting in the position.
• Maintain CIP certification once obtained

• 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

• 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
• Receives a CIP credential which serves the purpose of periodically reaffirming appropriate knowledge of regulations, specifically expedited review criteria for approval
• 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
• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
• Attendance and punctuality are essential functions of the position.