Clinical Trials Regulatory Coordinator

Virtua; Moorestown Township, Northern (NJ, KY); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Virtua is seeking a Regulatory Coordinator to coordinate regulatory activities for phase II-IV clinical trials. The role involves preparing and submitting IRB documents, maintaining study files, and ensuring compliance across central and external IRBs.

Local onsite work requires proximity to Marlton, NJ, with collaboration across the clinical research team. Responsibilities include preparing renewals, amendments, adverse event reporting, and maintaining communications with investigators and IRB

Qualifications

• Minimum of 3 years supporting regulatory activities in clinical research, preparation of IRB applications, and coordination of protocol approval.
• Able to function independently with strong organizational and interpersonal abilities.
• Experience ensuring regulatory documents meet timelines and compliance standards.

Responsibilities

• Prepares and submits regulatory documents for IRB and external review committees, including amendments and continuing reviews.
• Maintains regulatory documents for assigned protocols and supports audits and quality checks.
• Coordinates communication between study sites, investigators, and IRB staff to ensure timely filings.
• Handles regulatory training, documentation updates, and regulatory SOP development.
• Supports financial and administrative aspects related to regulatory operations and study activation.

Skills

Strong organizational skills

Excellent communication and Interp...

Education

Associate degree

Bachelor’s degree preferred

Job description

Virtua is seeking a Regulatory Coordinator to coordinate regulatory activities for phase II-IV clinical trials. The role involves preparing and submitting IRB documents, maintaining study files, and ensuring compliance across central and external IRBs.

Local onsite work requires proximity to Marlton, NJ, with collaboration across the clinical research team. Responsibilities include preparing renewals, amendments, adverse event reporting, and maintaining communications with investigators and IRB