Regulatory Coordinator

Lifespan
United States, Rhode Island, Providence
Nov 11, 2024
Summary: The Regulatory Coordinator performs multiple tasks in order to meet compliance requirements in research. This position will be overseeing clinical research regulatory requirements for the department. The Regulatory Coordinator will provide support in managing clinical trials for the department. The Regulatory Coordinator is to be responsible for clinical studies through the regulatory portion of the trial submission process to maintaining the regulatory integrity of assigned clinical trials from approval to closure. The Regulatory Coordinator instructs and advises other staff in regulatory/compliance issues and collaborates with investigators to resolve all regulatory inquiries. Responsibilities: Consults with and/or provides advice regarding regulatory documents and/or processes related to clinical trials conduct. Serves as the regulatory subject matter expert through all phases of a clinical study. Serves as a lead and mentor to other clinical research staff to include the execution of new initiatives and process improvement. Develops and/or revises regulatory policies and procedures. Initiates and leads special projects to include process improvement and regulatory training. Ensures proper regulatory compliance in accordance with sponsoring agency requirements. Liaises with sponsors investigators and team members providing trial information and updates as required in written oral and meeting format adhering to appropriate timelines. Develops protocols with the Principle Investigator and provides recommendations on research plan. Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications. In collaboration with the Principle Investigator interprets protocols and creates consent documents needed for clinical research study. Prepares regulatory approval applications respond to stipulations and shepherd applications and correspondence through the processes until approvals are obtained. Participates in Study Initiation Visits and Interim Monitoring Visits. Maintains study specific regulatory binder. Performs other duties as assigned. Other information: BASIC KNOWLEDGE: Bachelor*s degree in health-related or scientific field is required. Sound knowledge of all federal local and state guidelines pertaining to Clinical Research. Must be an independent person who is capable of making sound judgment pertaining to regulatory issues and have the ability to work independently within the scope of the job requirements. Strong-self-starter interpersonal skills and influence are necessary Team-oriented with excellent oral and written communication skills Strong problem-solving skills Excellent self- management and organizational skills Detail-oriented Computer skills in Microsoft office Comprehensive knowledge of FDA guidelines Must be proficient in various database applications Ability to foster smooth communications and teamwork among clinical research faculty fellows and staff as well as external organizations necessary SoCRA (Society of Clinical Research Associates) certified or eligible within 18 months of hire EXPERIENCE: 3-5 years in direct clinical trial administration experience or relevant clinical development and regulatory experience Understanding of compliance requirements with federal state or local programmatic regulations are necessary WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS: This position is a sedentary position. One must be able to transport paperwork to another building (sometimes up to 10 lbs.) at one time. Bending and stooping may also be requirements for filing of paperwork. Standing to copy may also be required. INDEPENDENT ACTION: This position requires a quick-thinker who can independently make basic and sometimes complex decisions pertaining to the completion and transmission of required regulatory documentation to internal departments as well as external agencies including but not limited to study sponsors local and federal agencies. The candidate should be able to answer protocol regulatory inquiries from researchers and physicians as well as from the local Institutional Review Board. This person should also be able to work with outside monitors and work independently. He/she should be able answer inquiries related to regulatory issues and if not known communicate with the correct person to determine the answer. SUPERVISORY RESPONSIBILITY: None Brown University Health is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status. Brown University Health is a VEVRAA Federal Contractor. Location: The Miriam Hospital USA:RI:Providence Work Type: Full Time Shift: Shift 1 Union: Non-Union Apply