Senior Clinical Research Associate

NAMSA

Senior Clinical Research Associate managing clinical studies for ensuring human subject protection and compliance. Collaborating with teams to monitor trial activities and support regulatory submissions.

Posted 7/30/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $68,800 - $133,700 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including site monitoring, regulatory compliance, and quality assurance. Proficient in communication and organizational skills to effectively manage study-related activities and support site operations.

Highest-signal resume keywords

Clinical Trial ManagementSite MonitoringRegulatory ComplianceGood Clinical Practice (GCP)Study Documentation Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ProcessesSite QualificationSite InitiationQuality Control ReviewData ManagementTrial Master File MaintenanceAdverse Event TrackingStudy Metrics TrackingLiterature SearchesCRF Development

Soft Skills

Verbal CommunicationWritten CommunicationOrganizational SkillsIndependent Work

Tools & Technologies

Clinicaltrials.govStudy Monitoring PlanStudy ToolsTemplatesTrackers

Certifications & Qualifications

Society of Clinical Research Associates (SoCRA)Association of Clinical Research Professionals (ACRP)

Industry Keywords

Good Clinical Practice (GCP)Human Subject ProtectionClinical Site MonitoringStudy Start-Up ActivitiesSite Budget CoordinationAudit PreparationDevice Trial ExperienceStudy EnrollmentRegulatory Authorities SubmissionsClinical Study Manager (CSM)

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.
Assess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection process.
Assists with the coordination of the site budget and contract negotiations as directed by the project lead(s).
Assists in preparing sites for audits and in resolving audit action items.
Supports sites during audits remotely and/or onsite as needed.
Participates in meetings with prospective clients.
Supports training and mentoring of CRAs during remote and onsite visits.
Manages the development and/or maintenance of study monitoring plan, templates, trackers, study tools, and site-specific documents.
Assists Clinical Study Manager (CSM) with development of human clinical protocol, investigational plan/brochure, SIV training presentations, and study operations development.
Supports Core Laboratory management and may serve as the primary contact.
Supports data management in CRF development, validation rules, UAT, review data and identify trends, and other reporting/analysis tasks.
Performs and summarizes literature searches.
Registers trials on Clinicaltrials.gov

Requirements

What you’ll need

Fluency in English and local language, if different, required.
Higher education degree or equivalent education, training, and experience.
Preferred 5 years clinical trial experience.
Preferred 3 years monitoring experience.
Preferred 1 year device trial 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

401(k) matching
Flexible work hours
Paid time off
Health insurance
Professional development opportunities