Senior Clinical Research Associate
Location
Tennessee
Posted
8 days ago
Salary
0
Seniority
Senior
Job Description
Senior Clinical Research Associate
ICON plc
• Serve as the primary point of contact between investigational sites and the sponsor • Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out • Ensure site compliance with ICH-GCP, SOPs, and regulations • Maintain up-to-date documentation in CTMS and eTMF systems • Support and track site staff training and maintain compliance records • Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting • Support subject recruitment and retention efforts at the site level • Oversee drug accountability and ensure proper storage, return, or destruction • Resolve data queries and drive timely, high-quality data entry • Document site progress and escalate risks or issues to the clinical team • Assist in tracking site budgets and ensuring timely site payments (as applicable) • Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
Job Requirements
- A graduate with a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN
- Eligible to work in United States without visa sponsorship
- A clinical research professional with 3+ years of on-site monitoring experience in the pharmaceutical or CRO industry
- Experienced monitoring Oncology (i.e. Prostate Cancer, and Lung Cancer) and/or Hematology oncology trials
- Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
- A clear communicator, problem-solver, and collaborative team player
- Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in Knoxville, TN near major HUB airports to support efficient regional travel
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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