Clinical Regulatory Associate

Clinical Regulatory Associate

Location: Pharmaron Baltimore Campus, Baltimore

About Pharmaron

Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programs, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit www.pharmaron.com.

Job Summary

Pharmaron is seeking a detail-oriented Clinical Regulatory Associate to manage essential clinical trial documentation, IRB submissions, and study start-up activities. This role is critical to ensuring compliance and smooth execution of clinical studies.

Key Responsibilities

• Create and maintain Investigator Site Files and Trial Master File
• Prepare and submit initial and continuing IRB submissions
• Generate essential study documents (FDA 1572, Financial Disclosure Forms, etc.)
• Report deviations, violations, and Serious Adverse Events to the IRB
• Coordinate protocol-specific staff training and delegation logs
• Maintain current approved protocols, consent forms, and Investigator Brochures
• Support monitoring visits and study closeout activities
• Ensure compliance with GCP, GLP, and internal procedures

Qualifications

• High school diploma required; Associate degree preferred
• Entry-level experience in a clinical research environment required
• Knowledge of GCP/GLP standards preferred
• Strong organizational, communication, and time management skills
• High attention to detail and ability to manage multiple priorities

Position Details

• Full-time, exempt role (40+ hours/week)
• Office-based, temperature-controlled environment
• No travel required

Salary Range: $50k - $54k

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.