Regulatory Coordinator
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Location
This role is open to candidates working remote in the U.S.
Company Information
At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each person is not only valued but empowered to thrive and make a meaningful impact.
Company Culture
Our people--both employees and consultants—are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.
Job Overview Summary
The Regulatory Coordinator ensures compliance with regulatory requirements and Good Clinical Practice (GCP) standards in clinical research. This role manages IRB submissions and oversees studies from initiation through closure, ensuring regulatory integrity while supporting investigators and research staff.
Job Duties & Responsibilities
- Analyzes and implements applicable regulatory requirements, institutional policies, and guidance documents to ensure the protection, welfare, and safety of research participants.
- Ensures adherence to Good Clinical Practice (GCP) standards across all phases of clinical research.
- Coordinates the submission and review process for study protocols, amendments, continuing reviews, and reportable events by the Institutional Review Board (IRB), from study initiation through closure.
Basic Qualifications
- Bachelor’s degree with 3+ years of relevant experience OR associate’s degree with 4+ years of experience.
- Demonstrated experience with an electronic regulatory filing system
- Current training in human subjects protection education, Good Clinical Practice, and HIPAA Privacy
Preferred Qualifications
- Strong interpersonal and client interaction skills
- Strong communication and organization skills
- Certified Clinical Research Professional (CCRP)/Certified Clinical Research Coordinator (CCRC)/Society of Clinical Research Associates (SOCRA) or equivalent preferred