Job Description

Job Description

Job Description

The Clinical Research Associate (CRA) serves as the primary liaison between investigative sites and LumaBridge. CRAs are responsible for conducting all aspects of site management and monitoring in accordance with ICH GCP guidelines, FDA regulations, LumaBridge SOPs, and client protocols. This hands-on, highly visible role is critical to advancing the development of promising oncology therapies and ensuring clinical trial integrity and compliance.

Title : Clinical Research Associate

Location : This is a home-based position.

Responsibilities :

• Perform site selection, initiation, monitoring, and close-out visits across the LumaBridge clinical trial portfolio
• Track and manage progress of assigned sites including patient recruitment/enrollment, CRF completion/submission, source data verification, and query resolution
• Conduct site monitoring activities such as:
• Ensure Principal Investigator (PI) oversight
• Perform source data review and verification
• Review and reconcile essential documents
• Manage Investigational Product (IP) accountability
• Oversee lab/kit supply management
• Build and maintain strong relationships with site personnel and investigators
• Communicate regularly with sites to ensure compliance, enrollment progress, and understanding of study protocols
• Prepare and submit accurate visit letters and monitoring reports; update applicable CTMS accordingly
• Escalate deficiencies and issues appropriately and support corrective/preventative actions
• Support audit readiness and participate in audit preparations or follow-up as needed
• Review protocol deviations and data quality issues; suggest process improvements for assigned sites
• Collaborate with study team members to share site insights and contribute to continuous improvement
• Contribute to CRF development and conduct User Access Testing as assigned
• Demonstrate critical thinking and prioritize monitoring tasks to meet study timelines
• Assist with other duties as assigned

Qualifications:

Required:

• Bachelor’s degree in life sciences, biomedical sciences, or medical sciences
• Minimum 2 years of clinical research experience
• Minimum 2 years of experience at a CRO or Sponsor
• Independent field monitoring experience (both remote and onsite) in oncology clinical trials
• Proficient knowledge of ICH GCP and relevant FDA regulations
• Strong written and verbal communication and interpersonal skills
• Excellent time management and prioritization skills
• Highly proficient in Microsoft Office, EDC, and CTMS systems
• Fluent in English (written and verbal)
• Willingness and ability to travel up to 50% as required, to include possession of the appropriate qualifications per independent site regulations (to include but not limited to vaccinations)

Preferred:

• Early phase oncology experience
• Demonstrated success in building productive relationships with site and sponsor teams
• Experience with complex site management in oncology trials

Job Tags

Similar Jobs