Clinical Research Associate – Single Sponsor
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Job Description
Clinical Research Associate monitoring Austrian clinical sites for Syneos Health’s biopharmaceutical studies. Ensuring GCP compliance, data integrity, site performance and audit readiness.
Responsibilities:
- 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 staff performance, communicate serious issues and develop action plans
- Verify informed consent, subject confidentiality, safety and clinical data integrity
- Assess site processes and conduct source document review and medical record review
- Verify clinical data in case report forms and drive query resolution
- Support clinical study data review, capture and electronic data capture compliance
- Manage 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 track observations and action items to resolution
- Support subject/patient recruitment, retention and awareness strategies
- Manage site-level activities, communications, project objectives, deliverables and timelines
- Liaise with study site personnel and ensure site team training and compliance
- Attend investigator, sponsor, clinical monitoring and training meetings
- Support audit readiness, audit preparation and follow-up actions
- Maintain knowledge of ICH/GCP, regulations and company SOPs; complete assigned training
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 Austria
- Good computer skills and ability to embrace new technologies
- Fluency in German and English
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel for monitoring visits in Austria
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Total Self culture supporting authenticity and inclusion
- Diversity, equity and belonging initiatives
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