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Regulatory Affairs Senior Specialist
2 months ago
Iterative Health is at the forefront of utilizing artificial intelligence-driven precision medicine in the field of gastroenterology, aiming to enhance clinical trials focused on the treatment of inflammatory bowel disease (IBD).
Our innovative approach employs sophisticated machine learning and computer vision techniques to analyze endoscopic videos and various data types, enabling healthcare professionals to more effectively evaluate patients with potential gastrointestinal issues.
Our ultimate goal is to establish more significant endpoints that serve as improved indicators of therapeutic response and disease outcomes.
Position Overview:
We are in search of a Regulatory Affairs Senior Specialist to become a vital part of our team.
The selected candidate will operate under the guidance of the Director of Regulatory Affairs, primarily responsible for supporting the execution and adherence to compliance standards for Phase 2-4 pharmaceutical research studies.
This role requires a collaborative individual contributor who will engage with internal teams, clinical sites, and study sponsors, necessitating both administrative and regulatory responsibilities.
This is a pivotal moment in the Clinical Research sector. Our team is committed to advancing research by implementing efficient processes, with the mission of expediting treatment options to patients.
Key Responsibilities:
- Collaborate with clinical site personnel on the preparation, organization, data entry, and maintenance of regulatory compliance for essential documents.
- Facilitate successful study initiation, including communication and status reporting between clinical sites and sponsors.
- Submit Institutional Review Board (IRB) applications on behalf of sites.
- Participate in both internal and external audits.
Qualifications:
- In-depth expertise in clinical research, regulatory compliance, and Phase 2-4 sponsored clinical studies, with a comprehensive understanding of the Study Coordinator role at clinical sites.
- Previous experience as a clinical research coordinator is advantageous.
- Proficient in adhering to Good Clinical Practices (GCP), FDA essential document guidelines, and Standard Operating Procedures (SOPs).
- Experience in project management and/or leading functional teams, demonstrating strong organizational, decision-making, time management, multitasking, and prioritization skills.
- Proficient in Adobe, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams), and clinical trial management systems (CTMS).
- Confident and experienced in presenting to various internal and external stakeholders.
Benefits:
- Comprehensive Vision/Dental/Medical Insurance
- Life and Disability Insurance
- Parental Leave
- Stock Options
- Flexible Work Hours
- Unlimited Paid Time Off
At Iterative Health, we are dedicated to fostering an environment that reflects the diversity of the patients our technology serves. We are committed to cultivating an equitable and inclusive culture, including our hiring processes.
