Clinical Research Associate – Single Sponsor
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Belgium
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About the role
- 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 Pharmacoepidemiology Practice (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; immediately communicates/escalates serious issues to the project team and develops action plans
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- 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
- 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 Belgium
- Must demonstrate good computer skills and be able to embrace new technologies
- Fluency in French and Dutch for monitoring purposes
- Excellent communication, presentation and interpersonal skills
Benefits
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- career development and progression
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
site qualificationsite initiationinterim monitoringsite managementprotocol compliancepharmacovigilanceGood Clinical PracticeICH Guidelinesregulatory requirementsmonitoring experience
Soft skills
communication skillspresentation skillsinterpersonal skillsjudgmentexperience evaluationproblem-solvingaction planningescalation of issuesadaptabilityteam collaboration
Certifications
Bachelor’s degreeRN