Regulatory Associate Jobs

Come Join Our Growing Team!

We are seeking a Regulatory Associate to join our Quality and Regulatory team in Baltimore, MD! This is a hybrid-position.

As a Regulatory Associate, you will be responsible the overall management of all essential documents for the conduct of a clinical trial, as well as IRB and study-start-up submissions.

Responsibilities

• Create and maintain the Investigator Site File for all studies awarded to Pharmaron CPC.
• Perform initial and subsequent IRB submissions.
• Create protocol-specific training certificates for each version of the IRB approved protocol and distribute to applicable project team members.
• Prepare delegation of authority log for each study and update the Codes of Tasks in compliance with the IRB approved protocol.
• Work closely with Clinical Trial Monitors during monitoring visits.
• Generate all essential documents (i.e., Form FDA 1572, Financial Disclosure Forms, etc.) for submission to sponsor.
• Ensure all staff members complete protocol-specific training and sign the delegation of authority log prior to performing any study related duties.
• Ensure IND safety reports are submitted to the PI and IRB for review.
• Ensure all study closeout reports are submitted to the IRB at the end of the study.
• Post each version of the IRB approved protocol, informed consent form and Investigator Brochure for staff to review.
• Performs other job-related duties as assigned.
• Report deviations/violations and Serious Adverse Events to the IRB.

Education

• 2+ years of experience in a clinical research environment.
• Associate degree preferred.
• HS Diploma or GED required.