Clinical Research Associate – Oncology

This is a fully remote position, open to applicants in Kentucky, +1 more state.

📋 Description

• Act as the main liaison between investigational sites and the sponsor.

• Execute site selection, initiation, routine monitoring, and close-out visits.

• Guarantee site adherence to ICH-GCP, SOPs, and applicable regulations.

• Keep documentation current in CTMS and eTMF systems.

• Assist and monitor site staff training while maintaining compliance records.

• Oversee patient safety and ensure prompt and accurate reporting of AE/SAE/PQC.

• Aid in subject recruitment and retention initiatives at the site level.

• Manage drug accountability and ensure proper storage, return, or disposal.

• Address data queries and promote timely, high-quality data entry.

• Record site progress and escalate any risks or issues to the clinical team.

• Support in tracking site budgets and ensuring timely payments, as applicable.

• Collaborate with CTAs, LTMs, CTMs, and other cross-functional partners.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a related field, or qualification as a Registered Nurse.

• Must be eligible to work in the United States without requiring visa sponsorship.

• A minimum of 2 years of on-site monitoring experience in the pharmaceutical or CRO sector.

• Experience in monitoring Oncology (Prostate Cancer and Lung Cancer) and/or Hematology Oncology clinical trials.

• Strong knowledge of ICH-GCP, local regulatory standards, CTMS, and eTMF.

• Willingness and capability to travel up to 50% for on-site monitoring visits across the southeastern region.

• Preference for candidates based in Tennessee, near major HUB airports.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.