Clinical Research Associate II – Sponsor-dedicated
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Job Description
Clinical Research Associate monitoring clinical trial sites for Syneos Health, a fully integrated life sciences services organization. Ensuring GCP compliance, data integrity, and study delivery.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
- Ensure regulatory, ICH-GCP/GPP, protocol, and site compliance
- Evaluate site and staff performance and communicate or escalate serious issues
- Verify informed consent, subject confidentiality, safety, clinical data integrity, and protocol compliance
- Conduct source document review and verify clinical data accuracy and completeness
- Resolve data queries and verify electronic data capture compliance
- Manage investigational product inventory, reconciliation, storage, dispensing, and returns as applicable
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document monitoring activities through letters, reports, logs, and project documentation
- Support subject recruitment, retention, and awareness strategies
- Track observations, action items, site status, deliverables, budgets, and timelines
- Act as liaison with study site personnel and ensure site teams are trained and compliant
- Attend investigator, sponsor, project, and clinical training meetings
- Support audit readiness, audit preparation, and follow-up actions
- For Real World Late Phase: provide site support throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities, and suggest potential sites based on local knowledge
Requirements:
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Oncology experience will be a plus
- 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 65-75% on a regular basis
- Working knowledge of relevant regulations and company SOPs/processes
- Must complete assigned training as required
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate
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