Priya Balar

• Orchestrated end-to-end regulatory compliance for 40+ oncology trials, encompassing study initiation, maintenance, and closure, in strict accordance with GCP, ICH, and FDA regulations.
• Functioned as primary regulatory liaison, engaging with IRBs, sponsors, Contracts and Budgets, clinical teams, and internal quality assurance teams. Successfully resolved challenges through strategic problem-solving.
• Established and maintained meticulous records on industry-standard platforms such as CT.gov, OnCore CTMS, Florence, and SIP.
• Executed precise management of FDA submissions, covering study start-ups, amendments, and annual reports through CDER procedures.
• Led initiation of trials, overseeing documentation gathering, negotiation of institutional language, submission to regulatory boards, attendance at SIVs, and rigorous timeline tracking.

• Led preparation and submission of regulatory documents for multiple studies, ensuring compliance with regulatory standards.
• Mentored and trained new study personnel, contributing to development of a skilled and cohesive research team.
• Maintained all responsibilities of previous role in addition to more regulatory focus

Clinical Research Coordinator A

• Oversaw, coordinated, and executed multiple pulmonary transplant research protocols, adhering to GCP
• Provided essential support to patients enrolled in clinical studies, actively troubleshooting for multiple protocols.

• Formulated and maintained precise study data records, ensuring GCP compliance and establishing foundation for replicability, documented through a comprehensive study protocol.
• Spearheaded the organization and facilitation of community advisory board and staff meetings, fostering a collaborative research environment.