Job Title: Senior Clinical Research Associate I (Sr. CRA I)
Department: Clinical Operations
Reporting To: Lead CRA/Clinical Operations Lead (COL)
Role Overview:
The Senior Clinical Research Associate I (Sr. CRA I) plays a pivotal role in managing clinical trial site activities and ensuring compliance with regulatory standards, Good Clinical Practice (GCP), and study protocols. This role encompasses site qualification, monitoring, and close-out, in addition to mentoring junior CRAs and contributing to process improvements and project scope management.
Key Responsibilities:
Site Management and Monitoring:
Conduct site qualification, initiation, interim monitoring, and close-out visits on-site or remotely, ensuring protocol and regulatory compliance.
Evaluate site and staff performance, escalating significant issues and developing corrective action plans as needed.
Oversee informed consent processes and safeguard patient confidentiality.
Monitor site compliance with investigational product (IP) handling and storage requirements.
Data Integrity and Documentation:
Verify clinical data accuracy and completeness through source document review and case report form (CRF) verification.
Manage electronic data capture (EDC) compliance and resolve data queries promptly.
Maintain and reconcile Investigator Site File (ISF) with the Trial Master File (TMF).
Document site activities through confirmation letters, trip reports, and tracking systems.
Mentorship and Training:
Provide mentorship and training to junior CRAs, including performing sign-off visits as assigned.
Lead training sessions and global clinical monitoring meetings, supporting junior staff development.
Project Management:
Collaborate with site teams to meet project timelines, deliverables, and budgetary goals.
Support project-level audit readiness and assist with audit preparations and follow-ups.
Identify and address out-of-scope activities, proposing process improvements and operational efficiencies.
Real World Late Phase (RWLP) Support:
Manage site operations throughout the study lifecycle, including site identification and close-out.
Conduct chart abstraction and data collection for real-world evidence.
Develop and maintain country-specific informed consent forms in collaboration with the regulatory team.
Build relationships with sponsor affiliates, medical science liaisons, and local teams.
Advanced Contributions:
Participate in bid defense meetings, offering insights into site selection and operational strategy.
Act as a primary liaison with project site personnel, ensuring compliance and clear communication.
Qualifications:
Education and Experience:
Bachelor’s degree or RN qualification in a related field, or equivalent education/training and experience.
Strong understanding of GCP, ICH Guidelines, and applicable regulatory requirements.
Skills and Competencies:
Proficient in computer systems and adaptive to new technologies.
Excellent communication, presentation, and interpersonal skills.
Demonstrated critical thinking and problem-solving abilities.
Capability to travel up to 75% regularly.
Why Join Syneos Health?
Career Development: Extensive opportunities for growth, training, and mentorship.
Inclusive Culture: A Total Self culture promoting diversity, authenticity, and belonging.
Industry Impact: Collaborate on projects involving groundbreaking therapies and real-world evidence.
Additional Information:
Responsibilities and qualifications are subject to company discretion and adjustment.
Syneos Health complies with all relevant regulations, including providing reasonable accommodations under the Americans with Disabilities Act (ADA).
Join us to make a meaningful impact— Work Here Matters Everywhere.
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