Clinical Research Associate-Freelance

TRIO - Translational Research in Oncology; United States; Remote; USD 70,000 - 120,000; Full time

Job summary

TRIO - Translational Research in Oncology is seeking a Clinical Research Associate (CRA) or Senior CRA for a remote, full-time, independent contractor role. Applicants must be based in the United States, with preference for Central or Western regions.

The position involves monitoring activities, site visits, and ensuring regulatory compliance across oncology trials. The ideal candidate has 3+ years of oncology CRA experience, 1+ year of early-phase monitoring, and strong ICH-GCP knowledge.

Qualifications

• Minimum 3 years oncology CRA experience across roles (CRA/SC/Research Nurse).
• Minimum 1 year monitoring experience on early phase trials.
• Strong knowledge of ICH-GCP guidelines and clinical monitoring.

Responsibilities

• Perform data verification of source documents and monitor sites.
• Conduct pre-study, initiation, monitoring, and termination visits.
• Ensure compliance with FDA/ICH-GCP and local regulations.
• Support data validation and resolve queries as needed.
• Mentor junior team members and manage regulatory documents.

Skills

Oncology CRA experience

Monitoring experience

ICH-GCP knowledge

English fluent

Travel up to 60%

Education

Bachelor's degree in science

Job description

If you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO could be the place for you! Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

TRIO is looking for a Clinical Research Associate (CRA) or Senior Clinical Research Associate (Senior CRA) to join our Monitoring Resources team. This is a remote Independent Contractor opportunity under a one-year contract requiring full-time availability. Applicants must be based in the United States , with preference given to candidates located in the Central or Western regions.

Responsibilities

• Performing data verification of source documents;
• Conducting site visits, including pre-study, initiation, monitoring, and termination;
• Confirming adherence to all FDA, ICH-GCP, and local regulations;
• Ensuring implementation and compliance with FDA, and ICH-GCP guidelines
• Assisting with data validation and query resolution
• Mentoring junior team members as required
• Ensuring the completion and collection of regulatory documents

Qualifications

• A minimum of 3 years of oncology experience as a CRA, Clinical Research Coordinator, and/or Research Nurse;
• Minimum of 1 year monitoring experience on an early phase trial
• Experience monitoring Phase I trials will be valued.
• Experience in solid tumor trials, including breast, lung, gastric, ovarian, and/or pancreatic cancer, is preferred;
• Fluent in English
• Completion of a science-related Bachelor’s degree
• Excellent knowledge of medical terminology and clinical monitoring process
• Strong ICH-GCPs knowledge
• Experience with clinical trial information systems
• Ability to travel up to 60% on average
• Must be legally authorized to work in the United States.

The contract rate and seniority level will be determined based on the applicant’s education, relevant experience, location, knowledge, skills, and abilities, as well as internal equity and market data.

Teamwork Passion Integrity Innovation