Lead Regulatory Affairs Coordinator

2 weeks ago

Chicago Illinois, United States Northwestern Memorial Healthcare Full time

Position Overview:
The Lead Regulatory Affairs Coordinator embodies the mission, vision, and values of Northwestern Memorial Healthcare (NMHC). This role is essential in ensuring adherence to the organization's Code of Ethics and Corporate Compliance Program, while also complying with all relevant policies, procedures, guidelines, and regulatory standards.

Key Responsibilities:
Under the supervision of the Stem Cell Transplant and Cell Therapy - Autoimmune Diseases Program Manager, the incumbent will oversee all regulatory aspects concerning the protection of human subjects involved in studies conducted within the Program.

This position is pivotal in managing the submission process to the Institutional Review Board (IRB) for new studies, particularly those involving complex protocols that present more than minimal risk to research participants.

The submission process entails the completion of comprehensive and detailed forms that summarize all facets of a research study, alongside the creation of new informed consent documents for research subjects.

The Lead Regulatory Affairs Coordinator must possess the capability to interpret specialized research protocols related to stem cell transplant and cellular therapy products, along with a solid understanding of federal regulations governing medical research.

Acting on behalf of Principal Investigators, this role will address IRB inquiries, concerns, and requests regarding any aspect of clinical research studies until the necessary approvals are secured.

This position serves as the primary liaison between Principal Investigators, sponsoring organizations, and the IRB. Additionally, it involves the management of regulatory operating policies and procedures for the Clinical Research core, providing expertise to Investigators on regulatory guidelines, compliance reporting, and submissions.

Additional Duties:
- Manage the submission of all regulatory documents to the IRB, including the development of informed consent forms and protocol reviews for complex studies.
- Independently conduct high-acuity protocol reviews with minimal guidance from investigators or Research Team Members.
- Prepare submissions to ancillary departments, IND applications, and renewals, while maintaining correspondence with the FDA throughout the IND process.
- Submit study renewal applications and progress reports to the IRB.
- Train research staff on the submission process in eIRB, offering guidance on form preparation and critical policy issues.
- Interpret existing and new regulatory requirements and Institutional Regulatory Policies related to human subjects research, effectively communicating these to research staff.
- Stay informed on federal and institutional guidelines governing research, recommending and implementing regulatory process improvements.
- Develop and manage an internal monitoring and auditing program, preparing for and participating in all internal and external audits, and interacting with regulatory agents and sponsor monitors.
- Ensure that regulatory binders, including electronic regulatory binders, are well-maintained and organized.
- Communicate with the IRB, administrative units, project sponsors, and project staff to ensure the accuracy of regulatory documents and submissions.
- Monitor study closure activities and coordinate project close-out with study sponsors and investigators.
- Track study approvals and expirations to maintain uninterrupted project approval, managing the regulatory database and electronic filing of all documents.
- Perform other assigned duties as necessary.

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