Clinical Research Regulatory Manager

New York, New York Research Institute – Research Full Time

The New York Stem Cell Foundation (NYSCF) Research Institute is a growing and successful nonprofit whose mission is to accelerate cures through stem cell research.

NYSCF is seeking a Clinical Research Regulatory Manager to manage all regulatory activities of the clinical research department. In this role, you will report directly to the Senior Vice President, Research.

What you'll do:

Clinical research administration and compliance

• Write, modify, and submit all IRB protocols, continuing reviews, informed consent forms, and other study documents in a timely manner.
• Manage all communications, required reporting, and documents involving IRBs and government agencies.
• Oversee and support all clinical research activities, including recruitment, enrollment, and informed consent.
• Create and modify department SOPs that reflect best practices and comply with applicable legal requirements.
• Oversee all study documentation, including regulatory binders, delegation logs, and other materials.
• Perform QA/QI activities to identify and implement program improvements.
• Ensure that research and related activities comply with all applicable regulations, laws, policies, and IRB requirements.

Institutional duties

• Assist with the preparation of grant applications and other activities to facilitate collaborations and philanthropic support.
• Prepare progress reports for funding agencies and presentations for sponsoring and regulatory agencies.
• Represent the clinical research department at meetings, presentations, and other events.
• Serve as a subject matter expert for federal regulations and state laws governing and impacting human subjects research across NYSCF.
• Represent NYSCF at scientific conferences and other external events to provide exposure and build relationships.

Data management

• Work closely with other department staff to collect complete and accurate data from research subjects in a timely manner and ensure appropriate data entry.
• Ensure the secure storage of research data in accordance with legal requirements and approved protocols.

Oversight

• Oversee and manage all regulatory activities of the clinical research department.
• Monitor subject safety and report assessments to the appropriate parties.
• Address reports regarding compliance, monitoring, and other clinical research matters appropriately.
• Provide guidance, training, assistance, and leadership to other department staff.

Miscellaneous

• Other administrative, office support, and research duties as assigned.