What are the responsibilities and job description for the Clinical Supervisor position at Astrix?
Responsible for the execution and quality oversight of monitoring plans for assigned US-based clinical trials, ensuring compliance with regulatory standards and optimal trial execution across therapeutic areas.
Pay: Up to $85/hr
Type: Contract
Location: Ridgefield, CT
Key Responsibilities:
Trial Preparation:
- Execute monitoring plans and ensure overall quality of monitoring for 5-8 US trials across different phases.
- Conduct on-site visits and oversee CRAs, including co-monitoring and supervisory visits.
- Implement trial monitoring plans and track deliverables via clinical operations systems (e.g., BI CTMS).
- Deliver risk-based site monitoring and provide local training to trial teams.
- Support inspection readiness and lead preparation for US regulatory inspections.
Trial Conduct:
- Monitor and oversee site management activities conducted by CRO partners, ensuring compliance with ICH-GCP and trial protocols.
- Manage risks and issues at the country level, ensuring adherence to SOPs and monitoring plans.
- Perform Site and Monitoring Oversight visits and implement follow-up actions as needed.
- Collaborate with Site Management Lead (SML-r) to update training materials and trial documents.
- Facilitate communication and training for CT Managers and CRAs, providing re-training as necessary.
Qualifications:
- Education: Bachelor’s degree in Health Sciences, Nursing, or related field.
- Experience: Minimum of 5 years in on-site monitoring or 8 years in a regulated pharmaceutical or healthcare environment.
- Strong understanding of ICH-GCP, regulatory requirements, and trial protocols.
- Ability to manage multiple trials and lead cross-functional teams.
- Excellent communication, training, and risk management skills.
Salary : $80 - $85
