LEAD CLINICAL SITE AMBASSADOR - REMOTE USA

Advanced Clinical - King of Prussia, PA

Full-time - Mid Level

Remote - King of Prussia, PA

Administrative and Support Services

About the position

The Lead Clinical Site Ambassador (LCSA) plays a crucial role in managing clinical trial activities at assigned sites, ensuring compliance with regulations and guidelines. This position involves overseeing the Site Management activities of Clinical Site Ambassadors (CSAs) and maintaining relationships with study sites. The LCSA is responsible for developing and executing Monitoring Plans, supporting site identification and training, and ensuring that clinical trials are conducted according to Good Clinical Practice (GCP) and other regulatory standards. This role offers a significant opportunity to impact the clinical industry and contribute to the success of clinical trials.

Responsibilities

• Develop comprehensive Monitoring Plans (MP) for clinical trials.
• Coordinate study startup activities of the Clinical Site Ambassadors (CSAs).
• Lead Clinical CSA activities through site selection, activation, maintenance, and study closure.
• Establish clinical monitoring study milestones and ensure accurate tracking and reporting of study metrics.
• Prepare status reports and agendas as required.
• Effectively interact and communicate with the Study Execution Team (SET) and other functional areas.
• Conduct CSA activities at assigned sites, including co-monitoring visits as needed.
• Review monitoring visit reports and track report metrics to ensure compliance.
• Assist with resolution of Corrective and Preventive Actions (CAPAs) as needed.
• Mentor Lead CSAs and CSAs as assigned.

Requirements

• A minimum of four (4) years of clinical trial lead/management experience.
• An additional two (2) years of on-site monitoring and clinical research experience or education; industry certification preferred.
• Experience with management of complex protocols, preferably in oncology.
• A degree (BSc/MSc) or equivalent in life science, nursing, pharmacy, or a related health/medical area.

Nice-to-haves

• Certification as a member of ACRP/ICR/SoCSA preferred.
• Experience in multiple therapeutic areas.

Benefits

• Remote working options available.
• Opportunities for professional development and training.