CRA Risk-Based Monitoring
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Job Description
CRA conducting risk-based monitoring for Syneos Health’s biopharmaceutical clinical trials in Germany. Managing site visits, data integrity, regulatory compliance and patient safety.
Responsibilities:
- 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 recommend site-specific actions
- Communicate and escalate serious issues to the project team and develop action plans
- Verify informed consent processes, subject/patient confidentiality, safety, clinical data integrity, protocol compliance and pharmacovigilance issues
- Assess site processes and conduct Source Document Review of site source documents and medical records
- Verify clinical data entered in case report forms and electronic data capture compliance
- Resolve queries remotely and on site within agreed timelines
- Perform investigational product inventory, reconciliation, storage, dispensing and administration reviews
- Review Investigator Site Files and reconcile them with the Trial Master File
- Document monitoring activities through letters, trip reports, communication logs and project documents
- Support subject/patient recruitment, retention and awareness strategies
- Track observations, site status and action items to resolution
- Manage site-level activities and communications to meet project objectives, deliverables and timelines
- Act as liaison with study site personnel and ensure assigned sites and team members are trained and compliant
- Attend investigator, sponsor, clinical monitoring and training meetings
- Support audit readiness and audit follow-up actions
- Complete assigned training and maintain knowledge of applicable guidelines, regulations and company procedures
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 Germany, preferably in oncology
- Experience in risk-based monitoring is a plus
- Good computer skills and ability to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Fluency in German and English
- Ability to manage required travel of up to 75% on a regular basis for monitoring visits
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Total Self culture
- Diversity, inclusion and belonging initiatives
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