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.
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.
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.
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.
Other administrative, office support, and research duties as assigned.
What we're looking for:
Minimum of 5 years conducting human subjects research with increasing responsibility.
Extensive experience with IRB applications, including writing, editing, and/or providing a regulatory review of research protocols and other study documents.
Expertise in all relevant human subjects regulations, including the Common Rule and FDA IND/IDE/351 requirements.
Detail-oriented, with excellent critical thinking, organizational, and analytical skills.
Understanding of scientific data collection and management methods.
Strong written and oral communication skills.
Highly motivated, with the ability to work independently as well as part of a team.
Adaptability to work in a fast-paced and changing environment.
Proficiency with Microsoft Office.
Proficiency with database applications.
Master’s degree or higher in a clinical or scientific field.
Experience serving as an IRB administrator and/or board member.
CIP, CCRC, or equivalent certification.
Specific proficiency with REDCap.
We offer all full-time employees a comprehensive benefits package that goes into effect on the first of the month following your start date.
NYSCF is an equal opportunity employer and we value diversity in our company. It ensures equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, veteran status, or any other characteristic protected by law.
The mission of The New York Stem Cell Foundation is to accelerate cures for the major diseases of our time through stem cell research. In just over one decade, NYSCF has created not only foundational tools for using stem cells in basic research, but also pioneering technologies that will allow stem cells to be used therapeutically.