Are you a seasoned regulatory professional looking for a new challenge in clinical research? Stryde Research is hiring a Regulatory Affairs professional to join their team and manage regulatory activities across multiple sites and studies. 🌟
About Stryde Research 📝
Stryde Research is a Site Management Organization operating 20+ clinical research sites across the US, serving 1.5M+ patients through specialized clinics in dermatology, rheumatology, cardiology, and general medicine. With a strong focus on innovation and patient care, Stryde Research is scaling fast and looking for a regulatory professional to keep their regulatory house in order.
What You’ll Actually Do 📚
- IRB Applications: Prepare and submit IRB applications, amendments, continuing reviews, and reportable events for multiple sites.
- Essential Documents: Maintain essential documents, including 1572s, delegation logs, training logs, investigator CVs, medical licenses, and financial disclosures.
- Regulatory Submissions: Coordinate regulatory submissions with sponsors, CROs, and site teams, and track IRB approvals, renewals, and expiration dates.
- Protocol Deviations: Manage protocol deviations, including documentation, root cause analysis, CAPA implementation, and sponsor reporting.
- Site Training: Track site training completion and maintain training files per GCP requirements.
- Audit Readiness: Prepare sites for sponsor audits and FDA inspections, and conduct regulatory readiness reviews.
Requirements 📝
- Experience: 2+ years of experience in a clinical research regulatory role with multi-site experience.
- Regulatory Knowledge: Solid understanding of FDA regulations (21 CFR Parts 50, 56, 312), ICH-GCP, and IRB requirements.
- IRB Experience: Experience with central and local IRBs, including Advarra, WCG, and Sterling.
- Communication Skills: Excellent communication skills and ability to work independently.
What Makes You Stand Out 🤔
- Therapeutic Area Experience: Experience working in dermatology, rheumatology, or cardiology trials.
- SMO Experience: Background working with Site Management Organizations (SMOs) or site networks.
- eTMF Systems: Familiarity with electronic Trial Master File (eTMF) systems, such as Veeva, Florence, or Masterfile.
- Certifications: CCRP or ACRP certification demonstrating expertise in clinical research.
The Reality Check 📝
- Remote Work: This is a remote role, but requires overlap with US business hours for sponsor calls, IRB correspondence, and site coordination.
- Fast-Paced Environment: Be prepared to manage competing deadlines and priorities across multiple studies and sites.
Why Choose Stryde Research? 🌟
- Innovative Company: Opportunity to work with a fast-growing company in the clinical research industry.
- Collaborative Team: Work with a team of experienced professionals who share your passion for regulatory affairs.
- Career Growth: Opportunities for career growth and professional development.
How to Apply 📧
If you’re interested in this exciting opportunity, Apply Now 👇🏻:
https://www.linkedin.com/jobs/view/4324950072