Clinical Regulatory Associate

Clinical Regulatory Associate

Location: Pharmaron Baltimore Campus, Baltimore

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.

• 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 close‑out activities
• Ensure compliance with GCP, GLP, and internal procedures

• 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

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

$50k - $54k

As an Equal Employment Opportunity and Aff… Pharmaron is proud to be an Equal Employment Opportunity and Aff…