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    3 minutes ago

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Regulatory Compliance and Quality Management Specialist

2 months ago

Atlanta, United States Regulatory Affairs Professionals Society Full time

Sterling IRB is currently seeking a knowledgeable and dedicated professional to serve as a Regulatory Compliance and Quality Management Specialist. The Quality Management & Regulatory Compliance Specialist is responsible for assisting the Director of Quality Management & Regulatory Compliance with the Sterling IRB regulatory compliance and quality management program. The primary responsibilities of the Regulatory Compliance and Quality Management Specialist include assisting with the following to assure continuous quality and compliance of the HRPP: Quality Management Assists with developing new policy or revisions to existing policy, to ensure proper implementation by the Board and/or administrative staff, as designated by the IRB Chairman and Institutional Official. Assists in areas within the IRB, as noted by the Quality Management & Regulatory Compliance department, or as recommended by the management team, where noncompliance with policy has been identified. Evaluation of:

Training and Education Program for the Board and Staff Board meetings, to ensure compliance with policy and regulations Meeting minutes to ensure that IRB meetings are accurately documented Internal file audits to ensure compliance with Sterling IRB policies and procedures and applicable regulations IRB Membership (at large), Individual Board Members Web content

Education Assist with dissemination of information and documentation of educational programs pertaining to regulatory compliance in human research protections and IRB review processes for members of the IRB and administrative staff. This will include orientation for new Board members and administrative staff, and continuing education on new/revised standard operating procedures and appendices. Assist with the maintenance of the Education/Training files for Board members and Administrative staff Review periodicals, literature, online discussion boards, and websites to remain apprised of current IRB regulatory issues. Audits Scheduling, preparing for, facilitating, and responding to sponsor/CRO audits. Coordinating and facilitating routine site audits. Preparing for and coordinating for cause audits of research sites as requested by the Board. Vendor Relationships The Sterling IRB vendor management process, including risk/impact assessment of new and existing vendor relationships. Completion and response to vendor questionnaires for existing and prospective clients of Sterling IRB Site and Sponsor Concerns Assist with triage of incoming regulatory compliance concerns from research sites and sponsors. Regulatory Correspondence / Compliance-Related Board Requested Follow-up Assist with preparation and dissemination of regulatory correspondence, including compliance-related Board requested follow-up. Standard Operating Procedures Assist with routine revisions to the Standard Operating Procedures (SOPs) and Appendices at the direction of Regulatory Compliance management staff. Assist in the quality assurance review of controlled documents Assist in the document change control process and retention of the Sterling IRB SOPs Meeting Minutes Assist with preparation of the IRB meeting minutes Assist with development and updates to the meeting minutes templates and agenda templates Accreditation Assist in the maintenance and revision of Sterling IRB’s policies and procedures in accordance with the requirements of the accrediting body Sterling Web site Responsible for recommending updates to the Sterling IRB web site to remain in accord with new/revised Sterling SOPs, as needed. Assist in the evaluation of the Sterling IRB web site to ensure content is accurate, relevant and meets the needs of Sterling IRB’s clients and study subjects Education/Training/Experience Required: Bachelor’s Degree with 2+ years of IRB experience CIP certification preferred Proficient computer skills and working knowledge of MS Office products Knowledge/Skills/Abilities Required: Knowledge of compliance requirements of all research related federal regulations governing human subject research. Regulatory requirements include, but are not limited to: FDA, DHHS/OHRP, GCP/ICH. Strong interpersonal, communication, analytical, and organizational skills Ability to work effectively with a wide range of internal and external stakeholders, including Board members, IRB administrative leadership, clients, and staff members Ability to excel in a team environment Ability to analyze information and solve problems Advanced oral and written communication skills Ability to manage conflicting demands and priorities

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