Overview
On Site
Depends on Experience
Contract - W2
Contract - 15 week(s)
Skills
regulatory submissions
GCP
EDC systems
clinical research
regulatory compliance
Job Details
Position Summary
The Clinical Research Regulatory Specialist is responsible for ensuring all regulatory aspects of assigned clinical trials and research studies are completed accurately, timely, and in compliance with institutional, state, federal, and Good Clinical Practice (Google Cloud Platform) guidelines. This role requires strong attention to detail, proficiency in electronic data capture (EDC) systems, and the ability to collaborate with investigators, research staff, and cross-functional teams to maintain regulatory integrity throughout the study lifecycle.
Required Qualifications
- Bachelor s Degree.
- Minimum 3 years of relevant clinical research experience.
- Demonstrated regulatory experience, with the ability to adhere strictly to regulatory and ethical guidelines.
- Proficiency with EDC systems, including Medidata, Veeva Vault, and MedRio.
Preferred Qualifications
- Oncology/Chemotherapy research experience.
- Certified Clinical Research Professional (CCRP) credential strongly preferred.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.