Clinical Research Associate II - Oncology
A
AbbViePharmaceutical Research
United StatesFull-TimeMiddle
SalaryUSD 84500 - 162000 / year
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Job Details
- Experience
- Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring
- Required Skills
- GCPCRM
Requirements
- Minimum of 1 year of clinically related experience.
- Minimum of 6 months of experience in clinical research monitoring of investigational drug or device trials.
- Advanced knowledge of local regulatory requirements, ICH/GCP Guidelines, and applicable policies.
- Familiarity with risk-based monitoring approaches (onsite and offsite).
- Strong planning, organizational, and cross-functional collaboration skills.
- Advanced ability to leverage technology and tools for customer-centric support.
- Excellent written, verbal, active listening, and presentation skills.
- Ability to think critically and apply good judgment to address site issues.
- Tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred.
- Knowledge of oncology therapeutic area indications preferred.
Responsibilities
- Serve as the primary point of contact for investigative sites, providing contextual information and strengthening site engagement.
- Train and motivate site staff and principal investigators on study goals, protocols, and patient treatment principles.
- Conduct site evaluation, training, monitoring, and closure activities in compliance with GCP, ICH guidelines, and AbbVie SOPs.
- Customize and execute site engagement strategies using CRM tools to track progress and measure impact.
- Perform continuous risk assessment and collaborate with the Central Monitoring team to detect site performance or patient safety issues.
- Identify, evaluate, and recommend new investigators and sites for planned clinical studies.
- Ensure data quality, timely submission, and audit/regulatory readiness at assigned sites.
- Manage investigator payments as per executed contract obligations.
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