Research Regulatory Associate, Early Drug Development

MSK

. Manage all regulatory tasks and documentation for clinical trials across multiple Principal Investigators and research study teams .

Posted 10/13/2026full-timeNew York City • New York • United StatesJuniorMid-Level💰 $69,400 - $107,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing regulatory tasks and documentation for clinical trials, ensuring compliance with human subject protection regulations and HIPAA. Possesses strong analytical, planning, and communication skills to effectively collaborate with internal and external stakeholders.

Highest-signal resume keywords

Clinical Research ExperienceRegulatory ComplianceHuman Subject Protection RegulationsHIPAA KnowledgeAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Documentation ManagementProtocol DevelopmentClinical Trial ManagementData AnalysisAudit Preparation

Soft Skills

Attention to DetailCritical ThinkingProblem-SolvingCommunication SkillsTeam Collaboration

Industry Keywords

Clinical TrialsPrincipal InvestigatorsResearch Study TeamsStudy TrendsExternal SponsorsCROs

About the role

Key responsibilities & impact

Manage all regulatory tasks and documentation for clinical trials across multiple Principal Investigators and research study teams
Maintain up-to-date documents and regulatory files to ensure MSK is audit-ready
Ensure protocol and policy compliance
Identify opportunities to contribute to team success with innovative ideas and solutions
Communicate overall study progress to internal and external partners
Identify study trends and build and implement solutions
Take ownership of key tasks while developing new skills and expanding knowledge
Serve as primary point of contact for external Sponsors/CROs
Participate in and/or lead weekly protocol meetings
Develop, revise, and maintain accurate protocol tools to ensure accurate conduct of clinical research
Report to the Research Project Manager

Requirements

What you’ll need

2 years of Clinical Research/Regulatory experience
Knowledge and understanding of regulations pertaining to human subject protection and HIPAA
Outstanding attention to detail and strong analytical skills
Capacity to operate autonomously and drive a high volume of work forward
Strong planning and prioritizing skills
Critical thinking and problem-solving abilities
Excellent communication skills and ability to interact across all levels in a confident, professional manner
Enthusiasm and dedication to MSK's vision, mission, and values