About this role
Job title: Senior Clinical Research Associate - Oncology - Knoxville, TN
ICON plc is seeking a Senior Clinical Research Associate – Oncology in Knoxville, TN. This role serves as the primary point of contact between investigational sites and the sponsor, conducting site visits, ensuring regulatory compliance, and supporting data quality and patient safety in oncology trials.
What You'll Do
- Serve as the primary point of contact between investigational sites and the sponsor.
- Conduct site visits including selection, initiation, routine monitoring, and close-out.
- Ensure site compliance with ICH-GCP, SOPs, and applicable regulations.
- Maintain up-to-date documentation in CTMS and eTMF.
- Support and track site staff training and maintain compliance records.
- Monitor patient safety with timely AE/SAE/PQC reporting.
- Support subject recruitment and retention at the site level.
- Oversee drug accountability and proper storage, return, or destruction.
- Resolve data queries and drive timely data entry.
- Document site progress and escalate risks or issues to the clinical team.
- Assist in tracking site budgets and ensure timely site payments (as applicable).
- Collaborate with cross-functional partners including CTAs, LTMs, and CTMs.
What We're Looking For
- Bachelor’s degree in Life Sciences or equivalent, or a qualified RN; eligible to work in United States without visa sponsorship.
- 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry.
- Experience monitoring Oncology (e.g., Prostate Cancer and Lung Cancer) and/or Hematology oncology trials.
- Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF.
- Clear communicator, problem-solver, and collaborative team player.
- Willing and able to travel up to 50% for on-site monitoring visits across the southeast region; preference for candidates residing in TN or KY near major hub airports.
Compensation & Benefits
- Salary: competitive.
- Benefits include: various annual leave entitlements; health insurance offerings; competitive retirement planning; Global Employee Assistance Programme, LifeWorks; life assurance; flexible country-specific optional benefits including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.