Senior Clinical Research Associate – Oncology

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

📋 Description

• Assists in identifying potential investigators for studies.

• Provides training, support, and guidance to Investigators and site personnel on study-related topics.

• Verifies that site staff have completed and properly documented the necessary training.

• Actively engages in Local Study Team (LST) meetings.

• Enhances site performance and ensures prompt resolution of study-related challenges.

• Conducts regular Site Quality Risk Assessments and adjusts monitoring intensity as needed throughout the study.

• Ensures timely resolution of data queries.

• Prepares for and collaborates on activities related to audits and regulatory inspections.

⛳️ Requirements

• Over 5 years of on-site monitoring experience in a CRO or pharmaceutical organization.

• At least 1 year of experience in oncology monitoring.

• Bachelor’s degree in a related field, ideally in life sciences, or an equivalent qualification.

• Strong knowledge of international guidelines such as ICH-GCP, with a foundational understanding of GMP/GDP.

• Familiarity with relevant local regulations.

• Solid medical knowledge and a willingness to learn about the client’s Therapeutic Areas.

• Basic understanding of the drug development process.

• Good grasp of Clinical Study Management, including monitoring, study drug handling, and data management.

• Exceptional attention to detail.

• Strong written and verbal communication skills.

• Effective collaboration and interpersonal abilities.

• Competent negotiation skills.

• Willingness to travel nationally and internationally as needed.

• Valid driver's license.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible work hours.

• Paid time off.

• Opportunities for professional development.