Clinical Research Associate II/Sr. Clinical Research Associate

Parexel

. Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP), applicable prevailing laws, GCP, and the Sponsor's standards .

Posted 9/24/2026full-timeRemote • Colorado • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge of clinical trial methodologies, ICH/GCP, and FDA regulations, with a strong ability to manage clinical trial activities and ensure compliance with protocols. Proficient in site monitoring, investigator training, and maintaining patient safety throughout the trial process.

Highest-signal resume keywords

Clinical Trial MethodologiesICH/GCP ComplianceSite MonitoringProtocol TrainingAdverse Event Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementSite ActivationDatabase Lock ProceduresProtocol Deviation ManagementData Query ResolutionInvestigational Product HandlingTMF DocumentationRecruitment InitiativesQuality Event RemediationCAPA Activities

Soft Skills

CommunicationCoachingProblem-SolvingCollaborationTraining

Industry Keywords

FDA RegulationsGCP StandardsClinical ResearchAdverse EventsInvestigator MeetingsPatient SafetyLife Sciences DegreeTravel RequirementsSite Personnel DevelopmentStudy Monitoring Plan

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP), applicable prevailing laws, GCP, and the Sponsor's standards
Manage operational aspects of clinical trial activities at assigned investigator sites from site activation through database lock
Serve as primary point of contact for assigned investigator sites
Facilitate information flow between study team members, vendors, and investigator sites
Perform investigator site development, coaching, and training of site personnel
Provide protocol training and address protocol-related questions
Support investigator meetings, enrollment, site activation, recruitment initiatives, and recruitment issue resolution
Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure
Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
Submit required reports, documentation, updates, and tracking, including TMF documentation, site reports, protocol deviations, recruitment, clinical supply management, study progress, and metrics
Identify and resolve investigator site issues and develop corrective and preventative actions
Resolve data queries and conduct investigator site close-out activities
Oversee investigational product receipt, handling, accounting, storage, and destruction
Support database release as needed
Maintain understanding of the product, protocol, and therapy area
Support patient safety, eligibility, and clinical guidance to investigators
Drive Quality Event remediation and audit CAPA activities when applicable

Requirements

What you’ll need

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Minimum 2 years relevant experience in clinical research site monitoring
Fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Benefits

Comp & perks

Equal opportunity employment without regard to legally protected status
Consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status