Clinical Trial Associate

Linical

. Provide administrative support to the project team .

Posted 10/8/2026full-timeRemote • United StatesJuniorMid-Level💰 $50,000 - $70,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research administration, including regulatory document preparation, project management support, and proficiency in Veeva Vault for eTMF. Strong communication and organizational skills are essential for effective collaboration within a matrixed team environment.

Highest-signal resume keywords

Clinical Research ExperienceRegulatory Document PreparationVeeva Vault ProficiencyCommunication SkillsAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsDocument ManagementProject TrackingSite Feasibility AssessmentInvestigator Site File CreationQuality Control ReconciliationTraining Document ManagementMeeting OrganizationBackground ChecksETMF Maintenance

Soft Skills

Interpersonal SkillsWritten CommunicationVerbal CommunicationTeam CollaborationTask Prioritization

Tools & Technologies

Learning Management SystemElectronic Trial Master FileProject-Specific TrackersStudy-Specific Documents

Industry Keywords

ICH GuidelinesGCPFDA RegulationsMHRA GuidelinesEMA Regulations

Tech Stack

Tools & technologies

Google Cloud PlatformVault

About the role

Key responsibilities & impact

Provide administrative support to the project team
Assist the Project Manager with communications to the project team and sites
Assist with site pre-identification and site feasibility
Collect initial essential documents from sites
Support study implementation activities, including regulatory and essential document preparation and IRB/IEC submissions
Create study-specific documents and materials
Maintain study organizational charts and project-specific trackers
Perform Principal Investigator background checks
Create Investigator Site Files and customize study templates
Upload and assign training documents in the Learning Management System and maintain the Project Team Training Matrix
Procure and ship study materials and supplies to sites and CRAs
Assist with Annual/Continuing Review IRB submissions in North America
Assist with meeting organization and prepare meeting minutes and action items
Request translations as required
File, review, classify, name, and maintain documents in the electronic Trial Master File according to the eTMF plan
Assist with periodic TMF quality-control reconciliation and project close-out
Create and structure project email accounts and assist with email filing
Maintain expert knowledge of Veeva Vault for eTMF and provide system user support
Perform other duties as assigned

Requirements

What you’ll need

Associate degree or equivalent experience
Minimum of two years of clinical research experience
Good written and verbal communication skills, including good command of English
Excellent interpersonal and communication skills
Awareness of ICH, GCP, FDA, MHRA, EMA regulations and local guidelines
Ability to work successfully in a matrixed team environment
Dedication to quality and attention to detail
Ability to prioritize and manage multiple tasks
Working knowledge of computer systems, applications, and operating systems
Ability to tolerate prolonged periods of sitting at a desk and working on a computer

Benefits

Comp & perks

PTO
Comprehensive benefits