Hybrid Research Regulatory Coordinator – Clinical Trials

Virtua Health; United States; Hybrid; USD 36,000 - 54,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

Paid time off

Tuition assistance

Life insurance

Job summary

Virtua Health is seeking a Regulatory Coordinator to coordinate regulatory activities for phase II-IV clinical trials, preparing IRB submissions, and maintaining regulatory documentation. You will liaise with local and external IRBs, ensure timely filings, and support audits while guiding study teams through activation processes.

Minimum 3 years in regulatory support, strong organizational and communication skills, and an Associate degree are required, with a Bachelor's preferred.

Qualifications

• Minimum of 3 years supporting regulatory activities in clinical research, preparation of IRB applications, preparation of investigator documentation, coordination of protocol approval process
• Able to function independently. Strong organizational skills. Excellent communication and interpersonal skills.
• Mandatory education on Human Subject and Good Clinical Practice education

Responsibilities

• Prepares and submits regulatory documents and correspondence for Institutional Review Board (IRB), including preparation of new and renewal applications, amendments, continuing reviews, reportable events , consent forms, revised consent forms, protocol deviations, adverse event reporting etc.
• Works with local IRB, external IRBs , Central IRB and research review committee to ensure all appropriate reports and required regulatory documents are completed and filed accurately and timely in compliance with regulatory agencies.
• Keeps Principal Investigators, sub-investigators and study team informed regarding regulatory operations and activation process.
• Manages and organizes regulatory study documentation and study files in accordance with sponsor, regulatory requirements and internal policies and procedures including, but not limited to, study protocols, consents, amendments, financial disclosure forms, FDA 1572 forms, study site logs and other essential documents.
• Develops regulatory standard operation and procedures that align with clinical research best practices.
• Prepares and organizes all regulatory documents for audits and monitoring visits. Participates in quality audits.
• Conducts administrative and regulatory activities related to support the conduct of clinical trials and daily operation of the clinical research program assisting with study implementation, study close-out, follow-up, and the facilitation of communication between study sites, principal investigators, sub-investigators, clinical research team and IRB.

Education

Associate degree

Bachelor's degree

Job description

Virtua Health is seeking a Regulatory Coordinator to coordinate regulatory activities for phase II-IV clinical trials, preparing IRB submissions, and maintaining regulatory documentation. You will liaise with local and external IRBs, ensure timely filings, and support audits while guiding study teams through activation processes.

Minimum 3 years in regulatory support, strong organizational and communication skills, and an Associate degree are required, with a Bachelor's preferred.