Regulatory Coordinator

Regulatory Coordinator

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.

Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate.

Responsibilities include:

• 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.
• Preparing and submitting clinical research trial packets to the Institutional Review Board.
• Ensuring proper regulatory compliance in accordance with ICH-GCP guidelines.
• Drafting and revising departmental regulatory procedures.
• Developing protocols with principal investigators and providing recommendations on research plans relating to drugs, devices and medical procedures.
• Coordinating submission of Investigational New Drug and Investigational Device Exemption applications.
• Preparing regulatory approval applications and responding to stipulations to ensure approvals.
• Participating in and conducting Study Initiation Visits and Interim Monitoring Visits.
• Reviewing and maintaining Regulatory Binders (FDA Form 1572, Financial Disclosure Form, CLIA, CAP)
• Assisting with training of clinical research staff on regulatory protocols of various clinical trials.
• Serve as the departmental regulatory expert through all phases of clinical trials.
• 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.

Minimum Qualifications:

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