This is a fully remote position, open to applicants in California.

📋 Description

• Oversee relationships with investigator sites and manage assigned clinical trial locations from activation to database lock and final close-out.

• Perform onsite and remote/electronic monitoring in line with monitoring plans, SOPs, GCP, and relevant regulations.

• Act as the main point of contact for designated investigator sites and facilitate the flow of information with study teams and vendors.

• Offer site development, coaching, protocol training, and recruitment assistance.

• Monitor adverse events and serious adverse events while collaborating with the Drug Safety Unit.

• Submit TMF documentation, site reports, follow-up letters, protocol deviations, and track recruitment and study progress.

• Identify and address site-related issues, developing corrective and preventative measures.

• Resolve data queries and carry out site close-out activities.

• Supervise the receipt, handling, accounting, storage, and destruction of investigational products.

• Provide support for database releases and unblinded monitoring when appropriate.

• Maintain knowledge of products, protocols, and therapy areas, ensuring patient safety and eligibility.

• Lead Quality Event remediation and audit CAPA activities when necessary.

⛳️ Requirements

• In-depth understanding of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• At least 3 years of relevant experience in clinical research site monitoring, with a preference for 2 years in Oncology.

• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

• Fluency in English and the native language(s) of the country of work is essential.

• Willingness to travel 60-80% of the time.

• A valid driver’s license and passport are required.

• Bachelor’s degree in life sciences or a professional degree in a life science field such as nursing, pharmacy, or a medical background, or equivalent qualification.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working arrangements and supportive work environment.