Clinical Research Associate II - Oncology Monitoring
Overview
The Clinical Research Associate II will lead site activities and ensure compliance with ICH-GCP standards. This role drives site operations and collaborates with cross-functional teams to achieve trial objectives. The ideal candidate thrives in a dynamic environment and contributes to innovative clinical development.
What You'll Do11
- 1Serve as primary point of contact between investigational sites and sponsor
- 2Conduct site visits for selection initiation monitoring and close-out
- 3Maintain up-to-date documentation in CTMS and eTMF systems
- 4Support site staff training and monitor compliance records
- 5Oversee drug accountability and manage storage return or destruction
- 6Resolve data queries and drive high-quality data entry
- 7Document site progress and escalate risks to the clinical team
- 8Track site budgets and ensure timely payments
- 9Collaborate with CTAs LTMs and CTMs
- 10Lead oncology trial monitoring and ensure patient safety
- 11Drive timely and accurate AE/SAE/PQC reporting
Requirements7
- 1Graduate degree in Life Sciences or equivalent RN qualification preferred
- 22+ years on-site monitoring experience in pharma or CRO industry
- 3Proficiency in ICH-GCP local regulations and CTMS/eTMF systems
- 4Experience monitoring oncology clinical trials especially hematology-oncology
- 5Ability to travel up to 50% for on-site visits in Southeast region
- 6Strong communication skills and ability to work collaboratively
- 7Eligibility to work in United States without visa sponsorship
Salary Insight
$91 - $114k per year
Location
Required Skills
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