Senior Clinical Research Associate - Freelance Remote

About the Role

We are seeking a Senior Clinical Research Associate - Freelance Remote to join our dedicated team at Translational Research in Oncology (TRIO). As a Senior Clinical Research Associate, you will play a crucial role in advancing translational cancer research through clinical trials. This position offers the flexibility of remote work while contributing to innovative cancer treatments that will impact patients globally.

What You'll Do

• Perform data verification of source documents to ensure accuracy and compliance.
• Conduct site visits, including pre-study, initiation, monitoring, and termination phases.
• Confirm adherence to all FDA, ICH-GCP, and local regulations throughout the clinical trial process.
• Ensure implementation and compliance with FDA and ICH-GCP guidelines.
• Participate in budget negotiation and follow-up where applicable.
• Assist with data validation and query resolution to maintain data integrity.
• Mentor junior team members as required, fostering a collaborative team environment.
• Ensure the completion and collection of all necessary regulatory documents.

Requirements

• A minimum of 2 years of monitoring experience in oncology trials.
• Experience monitoring in early-phase trials is highly valued.
• Completion of a science-related Bachelor’s degree.
• Excellent knowledge of medical terminology and the clinical monitoring process.
• Strong understanding of ICH-GCP guidelines.
• Experience with clinical trial information systems.
• Ability to travel up to 60% on average for site visits.
• Bilingualism in English and Spanish is required for effective communication.

Nice to Have

• Experience with remote monitoring techniques.
• Familiarity with electronic data capture systems.
• Previous involvement in protocol development.

What We Offer

• Opportunity to work in a global organization dedicated to cancer research.
• Engagement in innovative cancer research projects that make a difference.
• Flexible working hours to accommodate your schedule.
• A collaborative team environment that values your contributions.
• Professional development opportunities to enhance your skills and career.