Senior CRA I

Syneos Health

. Perform site qualification, site initiation, interim monitoring, site management and close-out visits, on-site or remotely .

Posted 11/4/2026full-timeRemote • MexicoSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site management, regulatory compliance, and clinical data integrity throughout the study lifecycle. Proficient in collaborating with study site personnel and managing site-level activities to ensure successful trial execution.

Highest-signal resume keywords

Site ManagementRegulatory ComplianceGood Clinical Practice/ICH GuidelinesChart AbstractionData Collection

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site QualificationSite InitiationInterim MonitoringSource Document ReviewClinical Data VerificationInvestigational Product ManagementTrial Master File ReconciliationAudit ReadinessPatient Recruitment StrategiesData Integrity

Soft Skills

Excellent CommunicationPresentation SkillsInterpersonal SkillsProblem-SolvingCollaboration

Tools & Technologies

Clinical Trial Management SystemsElectronic Data Capture SystemsMicrosoft Office SuiteProject Management Tools

Certifications & Qualifications

Bachelor’s DegreeRegistered Nurse (RN)

Industry Keywords

Clinical TrialsSite MonitoringRegulatory RequirementsReal World Late Phase Study DesignsInformed Consent Processes

About the role

Key responsibilities & impact

Perform site qualification, site initiation, interim monitoring, site management and close-out visits, on-site or remotely
Ensure regulatory, ICH-GCP/GPP and protocol compliance
Evaluate site and site staff performance and recommend site-specific actions
Communicate and escalate serious issues and develop action plans
Verify informed consent processes, subject confidentiality, safety and clinical data integrity
Assess site processes and conduct source document review
Verify clinical data in case report forms and resolve queries
Review investigational product inventory, reconciliation, storage, security, dispensing and administration
Review Investigator Site Files and reconcile them with Trial Master Files
Document monitoring activities through letters, trip reports, communication logs and project documents
Support subject/patient recruitment, retention and awareness strategies
Track observations, status and action items to resolution
Manage site-level activities, communications, objectives, deliverables and timelines
Liaise with study site personnel and ensure site teams are trained and compliant
Attend investigator, sponsor, monitoring, project and clinical training meetings
Support audit readiness, audit preparation and follow-up actions
Provide site support throughout the study lifecycle, including site identification through close-out
Perform chart abstraction and data collection
Collaborate with sponsor affiliates, medical science liaisons and local country staff
Train junior staff when requested
Identify and communicate out-of-scope activities
Suggest potential sites based on local treatment patterns, patient advocacy and healthcare provider associations

Requirements

What you’ll need

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Good computer skills and ability to embrace new technologies
Excellent communication, presentation and interpersonal skills
Ability to manage required travel of up to 75% on a regular basis
Knowledge of local requirements for real world late phase study designs
Ability to perform chart abstraction activities and data collection
Ability to collaborate with Sponsor affiliates, medical science liaisons and local country staff

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations when appropriate