Senior Clinical Research Associate
New
USFull-TimeSenior
Salary$108,500 – $201,500 (based on experience and skills)
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Job Details
- Languages
- English
- Experience
- 3+ years
Requirements
- Bachelor’s degree in life sciences, healthcare, or a related scientific field
- Minimum of 3+ years of clinical site monitoring experience in clinical research
- Strong knowledge of clinical trial processes, drug development, and ICH/GCP guidelines
- Experience managing multiple priorities in a fast-paced, regulated environment
- Excellent communication, problem-solving, and relationship management skills
- High attention to detail with strong organizational and documentation abilities
- Fluency in written and spoken English
- Willingness and ability to travel extensively (up to 80% nationally)
- Experience in oncology or advanced therapies (e.g., radioligand or CAR-T) is a plus
Responsibilities
- Serve as the primary point of contact for assigned investigational sites throughout the study lifecycle
- Conduct site initiation, monitoring visits (on-site and remote), and ongoing site support activities
- Ensure compliance with ICH/GCP, protocol requirements, SOPs, and applicable regulatory standards
- Monitor patient safety, data integrity, and timely resolution of data queries and issues
- Identify, assess, and escalate risks while implementing appropriate corrective and preventive actions
- Support inspection and audit readiness activities and ensure timely documentation updates
- Collaborate with cross-functional teams to optimize study timelines and operational efficiency
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