Senior CRA I

Syneos Health

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

Posted 11/11/2026full-timeRemote • MexicoSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site management, clinical data integrity, and compliance with Good Clinical Practice/ICH Guidelines. Proficient in managing investigational product inventory and supporting patient recruitment strategies throughout the study lifecycle.

Highest-signal resume keywords

Site QualificationGood Clinical Practice/ICH GuidelinesClinical Data IntegrityPatient Safety AssessmentInvestigational Product Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site InitiationSource Document ReviewData CollectionProtocol Deviation AssessmentElectronic Data Capture ComplianceChart AbstractionMonitoring Activities DocumentationAction Plan DevelopmentRegulatory Compliance KnowledgeClinical Trial Management

Soft Skills

Excellent Communication SkillsInterpersonal SkillsCritical Thinking SkillsPresentation SkillsMentorship Abilities

Tools & Technologies

Electronic Data Capture SystemsTrial Master FilesInvestigator Site FilesClinical Monitoring ToolsProject Management Software

Certifications & Qualifications

Bachelor’s DegreeRegistered Nurse (RN) Certification

Industry Keywords

Real World Late Phase StudiesPharmacovigilanceSite ManagementClinical Trial RegulationsAudit Readiness

About the role

Key responsibilities & impact

Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
Evaluate site and site staff performance and provide recommendations and action plans
Communicate and escalate serious issues to the project team
Verify informed consent processes and protect subject/patient confidentiality
Assess patient safety, clinical data integrity, protocol deviations, violations, and pharmacovigilance issues
Conduct source document review and verify clinical data entered in case report forms
Resolve queries remotely and on site and guide site staff toward resolution
Verify compliance with electronic data capture requirements
Manage investigational product inventory, reconciliation, storage, dispensing, and administration as applicable
Review and reconcile Investigator Site Files with Trial Master Files
Document monitoring activities through letters, trip reports, communication logs, and other project documents
Support subject/patient recruitment, retention, and awareness strategies
Track observations, status, and action items to resolution
Manage site-level activities and communications to meet project objectives, deliverables, and timelines
Liaise with project site personnel and ensure assigned sites and team members are trained and compliant
Prepare for and attend investigator and sponsor meetings
Participate in or lead clinical monitoring/project staff meetings and attend clinical training sessions
Support audit readiness and audit preparation and follow-up
Provide training or mentorship to junior CRAs and perform training/sign-off visits as assigned
Support site activities throughout the study lifecycle for real world late phase studies
Perform chart abstraction and data collection
Collaborate with sponsors, affiliates, medical science liaisons, and local country staff
Identify out-of-scope activities and suggest potential sites
Identify operational efficiencies and process improvements
Develop country-level informed consent forms
Collaborate with regulatory teams and participate in bid defense meetings

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
Basic level of critical thinking skills
Ability to manage required travel of up to 75% on a regular basis
Working knowledge of applicable regulations, company SOPs/processes, and relevant clinical guidance
Knowledge of local requirements for real world late phase study designs, where applicable

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, for employees or applicants with disabilities