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Syneos HealthCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in site management activities, including site qualification, monitoring, and compliance with Good Clinical Practice/ICH Guidelines. Proficient in data collection, patient recruitment strategies, and effective communication with study site personnel.
Highest-signal resume keywords
Site Management ActivitiesGood Clinical Practice/ICH GuidelinesData CollectionPatient Recruitment StrategiesCommunication Skills
About the role
Key responsibilities & impact- Perform site qualification, site initiation, interim monitoring, site management activities 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 documentation
- Protect subject/patient confidentiality and assess safety and clinical data integrity risks
- Assess site processes and conduct Source Document Review
- Verify clinical data in case report forms and resolve queries
- Use hardware and software for clinical study data review and capture
- Verify site compliance with electronic data capture requirements
- Manage investigational product inventory, reconciliation, storage, dispensing and administration as applicable
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document monitoring activities through required project documentation
- Support subject/patient recruitment, retention and awareness strategies
- Track observations, site status and action items to resolution
- Manage site-level activities, communications, deliverables and timelines
- Liaise with study site personnel and ensure site team training and compliance
- Attend Investigator Meetings, sponsor meetings, clinical monitoring meetings and training sessions
- Support audit readiness, audit preparation and follow-up actions
- Provide site support throughout the study lifecycle from site identification through close-out
- 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 using local knowledge of treatment patterns, patient advocacy and HCP 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
- Must comply with site requests for medical and other personal information required for facility access in the US
- 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
- Company car or car allowance
- Medical, Dental and Vision health benefits
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time
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 ReviewClinical Data VerificationChart AbstractionElectronic Data Capture ComplianceInvestigational Product ManagementMonitoring DocumentationAction Plan DevelopmentSite Performance Evaluation
Soft Skills
Excellent CommunicationInterpersonal SkillsPresentation SkillsCollaborationTraining Junior Staff
Tools & Technologies
Clinical Study Data Review SoftwareElectronic Data Capture SystemsTrial Master Files Management
Certifications & Qualifications
Bachelor’s DegreeRN in a Related Field
Industry Keywords
Site CompliancePatient ConfidentialityAudit ReadinessReal World Late Phase Study DesignsLocal Knowledge of Treatment Patterns