The Regulatory Coordinator III will prepare and submit protocols and supporting documents to regulatory bodies such as DSMC, PRMC, IRB, and IACUC.

This role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. Other duties include, representing the Medical Center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to ensure all regulatory documents and requirements are met and up-to-date. May plan and coordinate strategies for improving efficiency, action plans to improve quality, or training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

The Regulatory Coordinator III will be responsible for the oversight and coordination of regulatory aspects for all projects that are managed by the Translational Research Concierge (TRC) group. Responsibilities include independently managing and preparing submissions of new studies, modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB), Food and Drug Administration (FDA) and other ancillary committees including, Protocol Review and Monitoring Committee (PRMC).

The RAC III is responsible for effectively steering protocols through the regulatory committee process in a timely manner to ensure a prompt activation of trials and for all regulatory aspects of the protocols assigned. In addition, the RAC III serves as the liaison to sponsors, governing agencies and facilitates transmission of verbal and written communication to pharmaceutical companies, and other research entities. The incumbent must accurately maintain regulatory information in the clinical trial management system (OnCore), other databases, and systems as appropriate. The RAC III may conduct patient chart reviews, screen for eligibility, and consent patients. May support the development of study workflows to implement clinical research and activation of clinical trials as well as facilitate clinical research and clinical trial study closure.

Primary Duties and Responsibilities

• Prepares and submits protocols and supporting documents to regulatory bodies such as DSMC, PRMC, IRB, and IACUC. Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies. Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.
• Ability to identify areas of project interest and connect with appropriate support group: CCTO SPIN, IRB, Tech Transfer
• Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
• Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical research/clinical trials.
• Meets with monitors from pharmaceutical companies and represents the medical center during these meetings.
• Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
• Attends research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
• May participate in internal auditing of regulatory documents.
• May provide training and education to other personnel.
• May participate in centralized activities of the department or institution.
• May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs, clinical research, and develop guidelines as needed.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with organizational policies and procedures and develop guidelines/standard operating procedures (SOPs) as appropriate.

Other Duties and Responsibilities

• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.
• Ability to work with deadline driven structure and demonstrated experience in maintaining flexibility and adaptability while implementing institutional change. Ability to take initiative and demonstrate strong commitment to duties with a high level of integrity in compliance with regulatory management
• Develop Standard Operating Procedures for the Translational Research Concierge support group.

Requirements:

• BA/BS degree required
• Five (5) years minimum of directly related experience; 2 years of regulatory experience and 3 years of clinical research experience.