Clinical Research Project Associate

Cornell University

. Oversee all aspects of study coordination and study conduct for multisite investigator-initiated studies, focusing on large, pragmatic clinical trials .

Posted 11/11/2026full-timeNew York City • New York • United StatesMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including study design, regulatory submissions, and data management. Proficient in coordinating multisite studies and collaborating with stakeholders to ensure compliance with FDA regulations and Good Clinical Practice.

Highest-signal resume keywords

Clinical Trial ManagementRegulatory SubmissionsData ManagementGood Clinical PracticeStakeholder Coordination

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Study DesignData ManagementQuality AssuranceElectronic Data CaptureMonitoring PlansData Query ResolutionTraining DevelopmentPresentation SkillsProtocol DevelopmentMetrics Generation

Soft Skills

CollaborationCommunicationLeadershipProblem-SolvingTraining Support

Tools & Technologies

Clinical Research DatabasesElectronic Data Capture Systems

Industry Keywords

FDA RegulationsIRB RequirementsGood Clinical PracticeMultisite StudiesInvestigator-Initiated Studies

About the role

Key responsibilities & impact

Oversee all aspects of study coordination and study conduct for multisite investigator-initiated studies, focusing on large, pragmatic clinical trials
Manage study design, study conduct, data management, and quality assurance
Coordinate study activities with internal and external stakeholders in accordance with regulations, SOPs, and study-specific procedures
Serve as the primary contact for external subsites on project-related operational matters
Collaborate with the WCM Principal Investigator on study design, protocol, and informed consent form development
Complete regulatory submissions to PRMC, IRB, DSMC, and other agencies
Disseminate new and revised project documents to participating subsites
Create the electronic data capture system with developers and support protocol-specific database design
Generate subsite data completion metrics
Develop and implement project-specific monitoring plans and perform remote monitoring visits
Issue and resolve data queries and pending data entry
Plan subsite Site Initiation Visits and develop presentations, training, and educational materials
Provide ongoing training and study team support
Present study metrics, progress, and long-term goals at Steering Committee meetings
Lead project-specific study coordinator meetings
Provide updates and reporting to subsite study teams, the WCM PI, and internal collaborators
Streamline and facilitate communications with subsites
Perform other related duties as assigned

Requirements

What you’ll need

Bachelor's Degree
Approximately 3 or more years of related research experience in clinical trial management
Knowledge of FDA regulations, IRB requirements, Good Clinical Practice, and clinical research databases

Benefits

Comp & perks

Equal Employment Opportunity/Minorities/Females/Vet employer