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Clinical Country & Site Associate – Clinical Trial Manager
Syneos HealthClinical Country & Site Associate role ensuring compliance in clinical trials. Collaborate with teams to manage site activities and ensure regulatory adherence.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in site qualification, management, and compliance with ICH-GCP and Good Pharmacoepidemiological Practices. Proficient in evaluating site performance and ensuring patient safety and data integrity.
Highest-signal resume keywords
Site QualificationGood Clinical PracticeICH GuidelinesRegulatory ComplianceInformed Consent Verification
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 Data IntegrityProtocol CompliancePharmacovigilanceSite InitiationInterim Monitoring
Soft Skills
Excellent CommunicationPresentation SkillsInterpersonal Skills
Tools & Technologies
Computer SkillsNew Technologies
Certifications & Qualifications
Bachelor’s DegreeRN in a Related Field
Industry Keywords
Good Pharmacoepidemiological PracticesRegulatory RequirementsSOPs/Processes
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient
- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
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
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
Benefits
Comp & perks- We are passionate about developing our people, through career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- inclusive culture – where you can authentically be yourself