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Clinical Research Associate
Syneos Health. Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in site management, regulatory compliance, and clinical data integrity, with a strong focus on Good Clinical Practice and ICH Guidelines. Proficient in managing site-level activities and mentoring junior staff while ensuring effective communication and training.
Highest-signal resume keywords
Site QualificationRegulatory ComplianceGood Clinical PracticeClinical Data IntegrityFluency in English and German
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site ManagementClinical MonitoringData VerificationSource Document ReviewProtocol CompliancePharmacovigilanceInvestigational Product ManagementAction Plan DevelopmentClinical OperationsCritical Thinking
Soft Skills
Excellent CommunicationInterpersonal SkillsPresentation Skills
Tools & Technologies
Electronic Data CaptureTracking SystemsClinical Study Software
Certifications & Qualifications
Bachelor’s DegreeRN in a Related Field
Industry Keywords
ICH GuidelinesGCPClinical TrialsSite Staff PerformancePatient RecruitmentAudit Readiness
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, communicate serious issues, and develop action plans
- Verify informed consent, subject confidentiality, safety, clinical data integrity, protocol deviations and pharmacovigilance issues
- Assess site processes and conduct source document review and medical-record review
- Verify clinical data in case report forms and resolve queries remotely and on site
- Use hardware and software to support clinical study data review and capture
- Verify electronic data capture compliance
- Perform investigational product inventory, reconciliation, storage, dispensing and administration checks
- Review Investigator Site Files and reconcile them with the Trial Master File
- Document monitoring activities and enter observations and action items into tracking systems
- Support subject/patient recruitment, retention and awareness strategies
- Manage site-level activities and communication to meet project objectives, deliverables and timelines
- Act as liaison with project site personnel and ensure assigned sites and team members are trained and compliant
- Prepare for and attend investigator and sponsor meetings and clinical training sessions
- Provide guidance on audit readiness and support audit preparation and follow-up
- Mentor junior CRAs and perform training/sign-off visits as assigned
- Potentially perform clinical operations lead tasks under supervision
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
- Previous monitoring experience in Germany
- Good computer skills and ability to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Basic level of critical thinking skills
- Fluency in English and German
- Ability to manage required travel of up to 75% on a regular basis
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