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NAMSA

Clinical Research Associate – Internal Site Management

NAMSA

Clinical Research Associate ensuring Good Clinical Practice compliance through site monitoring for clinical trials. Collaborating with cross-functional teams and managing site communications effectively.

Posted 7/29/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-Level💰 $56,000 - $109,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in clinical trial management, ensuring compliance with Good Clinical Practice (GCP) and regulatory guidelines while effectively communicating with study teams and site investigators. Proficient in tracking study metrics and maintaining quality control of study documents.

Highest-signal resume keywords
Clinical Trial ManagementGood Clinical Practice (GCP)Site Monitoring ExperienceStudy Document ManagementFluency in English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Clinical Research ProcessesQuality Control ReviewStudy Metrics TrackingSite QualificationSite Initiation MonitoringSite Close-Out MonitoringAdverse Event TrackingTrial Master File MaintenanceStudy Start-Up ActivitiesRegulatory Submissions
Soft Skills
Verbal CommunicationWritten CommunicationOrganizational SkillsIndependent Work
Tools & Technologies
Clinical Trial Management SystemsQuality Review Tools
Certifications & Qualifications
Society of Clinical Research Associates (SoCRA)Association of Clinical Research Professionals (ACRP)
Industry Keywords
Human Subject ProtectionRegulatory GuidelinesContractual AgreementsStandard Operating Procedures (SOPs)Study Enrollment

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
  • Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
  • May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
  • Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
  • Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
  • Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
  • Performs study-related training.
  • Manages the development and maintenance of study documents, processes and systems as assigned.
  • Ensures quality and completeness of central and site master files.
  • Tracks and maintains required study documents, performs quality control review, manages renewals.
  • Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
  • Attends internal and external meetings as required.
  • Provides all job-related progress reports and visit documentation as required.
  • May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
  • OUS: Prepares and coordinates submissions to regulatory authorities.
  • May perform other activities as assigned.

Requirements

What you’ll need
  • Fluency in English and local language, if different, required.
  • Higher education degree or equivalent education, training, and experience.
  • Preferred 2 years clinical trial experience.
  • Preferred monitoring experience.
  • Able to work independently once trained.
  • Good verbal and written communication skills.
  • Strong organizational skills.
  • Basic computer proficiency.
  • Understanding of clinical research processes and regulations.
  • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.

Benefits

Comp & perks
  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible working arrangements
  • Professional development opportunities