Windsor, CT nandhishn@gmail.com LinkedIn Available for On-Site & Remote Roles

Career Direction

Clinical Research Regulatory Support & Study Start-Up

I am pursuing documentation- and coordination-focused roles supporting the regulatory side of clinical research: IRB and research-compliance workflows, essential documents, study start-up tracking, and protocol-driven operations.

Why this direction fits

Clinical research regulatory work calls for procedural accuracy, complete records, multi-party coordination, and careful communication.

Procedure-driven records

Judicial work requires accurate filings, confidential records, procedural review, and dependable follow-through across a high-volume docket.

Scientific context

Biology and chemistry training supports protocol comprehension, technical vocabulary, and communication with research teams.

Ethics-sensitive legal analysis

Legal education supports careful interpretation of requirements, clear documentation of reasoning, and respect for confidentiality and due process.

Tracking & coordination

Project reporting, audit support, data tools, and stakeholder coordination provide a foundation for start-up trackers and submission workflows.

Roles of interest

The emphasis is clinical research regulation and start-up—not participant-facing clinical care or independent monitoring.

Clinical Research Regulatory Coordinator Regulatory Coordinator I IRB Coordinator or Analyst I Study Start-Up Associate Site Activation Coordinator Clinical Trial Assistant Clinical Research Assistant

Areas I am developing

  • Human-subject protection and IRB submission workflows.
  • Good Clinical Practice concepts and protocol adherence.
  • Study start-up, site activation, and milestone tracking.
  • Essential-document and regulatory-binder organization.
  • Protocol amendment impact assessment and communication flow.

Transferable strengths

  • Reviewing documents for completeness and procedural sufficiency.
  • Maintaining accurate and confidential records.
  • Coordinating stakeholders, deadlines, and follow-up.
  • Turning complex requirements into organized checklists and written guidance.
  • Using Excel and data tools to improve visibility and consistency.

Transparent positioning

I do not claim prior IRB submissions, study activation, regulatory-binder maintenance, sponsor/CRO work, or clinical-trial operations experience. Clinical portfolio plans are independent educational exercises intended to demonstrate preparation and transferable judgment.

Review the Clinical Research resume

This version emphasizes regulatory coordination, study start-up support, documentation, records, and procedure-driven work.

Open PDF Resume