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Clinical Research Associate – Sponsor Dedicated
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, clinical data integrity, and compliance with Good Clinical Practice/ICH Guidelines. Proficient in managing investigational product inventory and supporting patient recruitment strategies while ensuring effective communication and collaboration with study site personnel.
Highest-signal resume keywords
Site ManagementGood Clinical Practice/ICH GuidelinesClinical Data IntegrityInvestigational Product ManagementPatient Recruitment Strategies
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 QualificationSite InitiationSource Document ReviewElectronic Data Capture ComplianceClinical MonitoringData CollectionChart AbstractionProtocol ComplianceAction Plan DevelopmentTrial Master File Reconciliation
Soft Skills
Excellent CommunicationPresentation SkillsInterpersonal SkillsProblem-SolvingCollaboration
Tools & Technologies
Clinical Trial Management SystemsElectronic Data Capture SystemsInvestigator Site FilesProject Management Tools
Certifications & Qualifications
Bachelor’s DegreeRegistered Nurse (RN)
Industry Keywords
Good Clinical PracticeICH GuidelinesRegulatory RequirementsReal World Late Phase StudiesSite Staff Performance Evaluation
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 recommend site-specific actions
- Escalate serious issues and develop action plans
- Verify informed consent processes, subject safety, confidentiality, protocol compliance, and clinical data integrity
- Assess site processes and conduct source document review
- Verify clinical data in case report forms and resolve queries
- Verify electronic data capture compliance
- Manage investigational product inventory, reconciliation, storage, dispensing, and administration as applicable
- Review Investigator Site Files and reconcile them with Trial Master Files
- Prepare confirmation letters, follow-up letters, trip reports, communication logs, and project documents
- Support subject/patient recruitment, retention, and awareness strategies
- Track observations, site status, and action items
- Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines
- Act as liaison with study site personnel and collaborate with Central Monitoring Associates
- Train assigned sites and project-specific site team members
- Attend investigator, sponsor, clinical monitoring, project staff, and clinical training meetings
- Support audit readiness and audit follow-up actions
- For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates, medical science liaisons, and local country staff, train junior staff, identify out-of-scope activities, and suggest potential sites
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
- Must comply with site requests for medical and other personal information when required for facility access in the US
- Working knowledge of company SOPs/processes
- For Real World Late Phase: knowledge of local requirements for real world late phase study designs
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Company car or car allowance
- Medical, dental, and vision health benefits
- Company match 401(k)
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time