Clinical Research Associate II/Senior Clinical Research Associate

Parexel

. Manage investigator site relationships and assigned clinical trial sites .

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

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive knowledge of clinical trial methodologies, ICH/GCP, and FDA regulations while effectively managing investigator site relationships and ensuring compliance with monitoring plans. Proficient in site initiation, monitoring, and close-out activities, with a strong focus on patient safety and quality assurance.

Highest-signal resume keywords

Clinical Trial MethodologiesICH/GCP ComplianceSite Monitoring ExperienceFluency in English and Native LanguageBachelor’s Degree in Life Sciences

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Site InitiationRoutine MonitoringRemote MonitoringAdverse Event MonitoringTrial Master File DocumentationData Query ResolutionInvestigational Product ManagementProtocol TrainingCorrective and Preventive ActionsStudy Progress Metrics

Soft Skills

CoachingTrainingProblem-SolvingCollaborationCommunication

Industry Keywords

Good Clinical Practice (GCP)Food and Drug Administration (FDA)Site Care PartnersClinical ResearchPatient SafetyEligibility CriteriaQuality Event RemediationCAPA ActivitiesMonitoring PlansLocal Country Regulations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Manage investigator site relationships and assigned clinical trial sites
Conduct site initiation, routine monitoring, remote/electronic monitoring, and site close-out activities
Ensure clinical trials comply with monitoring plans, applicable laws, GCP, SOPs, and sponsor standards
Serve as primary contact for assigned investigator sites and coordinate with study teams, vendors, and Site Care Partners
Provide site personnel coaching, training, protocol training, and recruitment support
Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management records, study progress, and metrics
Identify and resolve site issues, including corrective and preventive actions
Resolve data queries and support database release
Oversee investigational product receipt, handling, accounting, storage, and destruction
Support patient safety, eligibility, clinical guidance, quality event remediation, audits, and CAPA activities
May undertake unblinded monitor responsibilities where appropriate

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
Must be 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
Travel reimbursement or related travel support is not explicitly stated