Research Regulatory Coordinator - (Full-time, Hybrid)

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Job Summary:

Coordinates regulatory activities for participation in phase II -IV clinical trials. Prepares and processes all regulatory documentation to support the Clinical Research Program in managing IRB documents and protocols for the IRB, central IRB, external IRBs and all applicable regulatory review committees including new submissions, continuing reviews, amendments, adverse events, and reportable events. Organizes and maintains regulatory documents for assigned protocols. Participates in quality audits.

Position 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. Ensures all Principal Investigators, Sub-investigators and study team are up to date with all required regulatory training.

Attends study team meetings, sponsor meetings, and in-service education as required. Conducts financial tracking for clinical trials, invoicing sponsors and tracking payments received. Conducts internal audits of financials. Maintains protocol directory and updates Virtua website with clinical trial information. Develops and maintains various databases, prepares regular and ad hoc reports and forms as required. Orders clinical research supplies, office supplies, performs miscellaneous administrative activities as needed.

Position Qualifications Required:

Required Experience:

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.

Required Education:

Associate degree required; Bachelor's preferred.

Training / Certification / Licensure:

Mandatory education on Human Subject and Good Clinical Practice education

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