Tejashree Kulkarni
Manager-Research | Clinical Research Compliance | Non-Scientific IRB Reviewer
- Role
- Regulatory Affairs Manager at Rhode Island Hospital
- Location
- Providence, RI, US
- LinkedIn followers
- 500 followers
About Tejashree Kulkarni
A Dynamic leader with 10+ years of experience in clinical, regulatory, and quality assurance roles, skilled in driving operational excellence, leading teams, and delivering exceptional patient service. Proven ability to manage priorities in fast-paced environments and deliver impactful results.
Experience
Regulatory Affairs Manager
Oct 2024 — Present
Lead and develop a cross-functional team of 10+ research professionals, including coordinators, regulatory staff, and nurses, across 100+ active clinical trials spanning oncology, cardiology, endocrinology, and infectious diseases.Provide strategic and operational leadership throughout the clinical trial lifecycle—from feasibility and startup to closeout—ensuring timely execution and regulatory compliance.Drive enrollment performance by refining recruitment strategies and aligning team goals with protocol-specific objectives.Serve as the primary liaison with sponsors, CROs, and IRBs, maintaining strong relationships and ensuring consistent communication across Phase I–IV trials.Oversee study budgets, invoicing accuracy, and payment timelines while minimizing billing discrepancies.Implement new regulatory SOPs, quality checks, and administrative policies to enhance departmental efficiency and compliance.Lead quarterly quality assurance meetings and CAPA reviews to identify inefficiencies, execute improvements, and prepare for audits and inspections.Deliver ongoing training programs to ensure staff are updated on regulatory changes, internal processes, and industry standards.Report on study start-up timelines and regulatory metrics at team meetings to foster collaboration, transparency, and accountability.Collaborate with executive leadership on regulatory strategies for industry-sponsored, cooperative group, and investigator-initiated trials.
Education
Gokhale Education Society Science College
High School, Pure Science
2008 — 2010
Sinhgad College of Pharmacy
Bachelor's Degree, Pharmacy
2010 — 2014
Northeastern University
Master's degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
2015 — 2017
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