Senior Clinical Research Associate - US
RemoteUnited States
Job Summary
Conduct independent site visits for pre-study, initiation, interim monitoring, and closeout to ensure compliance, adequate enrollment, and understanding of study requirements. Independently perform CRF reviews, generate and resolve queries, and identify escalating risks or retraining opportunities for site personnel. Prepare corrective and preventive action plans, follow them to resolution, and handle EC submission documents and translations. Negotiate study budgets with investigators, assist in executing site contracts, and administer site payments per project instructions. Requires 3-5 years of oncology monitoring experience, ICH GCP knowledge, and a valid driver's license. Competitive salary and comprehensive benefits available.
Required Qualifications
- University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
- At least 3-5 years of independent clinical trial monitoring experience in oncology
- High level of knowledge of ICH GCP Guidelines
- knowledge of regulatory requirements
- strong interest in clinical research
- Computer proficiency
- Ability to read, analyze, and interpret common scientific and technical journals
- Excellent verbal and written communication skills
- Very good interpersonal and negotiation skills
- Ability to work independently, pro-active
- Affinity to work effectively and efficiently in a matrix environment
- A current, valid driver's license
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