Clinical Trial Site Operations Lead | GCP & Site Compliance

KCR Placement; Bell (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

ICON Strategic Solutions is seeking a Biosample Operations Specialist to support sponsor-dedicated monitoring of clinical trial sites, ensuring adherence to study protocols and regulatory requirements.

You will coordinate monitoring activities, assist with regulatory document preparation, and collaborate with cross-functional teams to optimize site performance. Travel ~25% is expected.

Qualifications

• Bachelor's degree in life sciences, healthcare administration, or clinical research.
• Experience in clinical research, site management, or monitoring with knowledge of GCP.
• Strong organizational and project management skills to handle multiple priorities and deadlines.
• Excellent analytical skills and attention to detail for high-quality standards.
• Exceptional communication and interpersonal skills to work with site personnel and cross-functional teams.
• Willingness to travel ~25%.

Responsibilities

• Coordinating monitoring activities at clinical trial sites, ensuring adherence to study protocols and timely resolution of site-related issues.
• Assisting in the preparation and review of regulatory documents, ensuring all site activities are compliant with GCP and applicable regulations.
• Collaborating with cross-functional teams to facilitate effective communication and support for trial sites throughout the study lifecycle.
• Tracking site performance metrics, analyzing data, and providing reports to enhance site management efficiency.
• Participating in training initiatives and mentoring junior staff to support their development in clinical trial management.

Skills

Clinical research

Site management

Project management

Analytical skills

Communication

Travel readiness

Education

Bachelor's degree in life sciences / healthcare / clinical research

Job description

ICON Strategic Solutions is seeking a Biosample Operations Specialist to support sponsor-dedicated monitoring of clinical trial sites, ensuring adherence to study protocols and regulatory requirements.

You will coordinate monitoring activities, assist with regulatory document preparation, and collaborate with cross-functional teams to optimize site performance. Travel ~25% is expected.