Senior Clinical Research Associate II – Oncology
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Job Description
Senior oncology clinical research associate monitoring clinical trials across Southern California. Managing sites, ensuring protocol compliance, reviewing data, and reporting adverse events.
Responsibilities:
- Provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards
- Perform routine monitoring and close-out of clinical sites
- Maintain study files
- Conduct pre-study and initiation visits
- Liaise with vendors
- Manage study sites according to project plans
- Ensure study staff receive proper materials and instructions to safely enter patients into the study
- Verify informed consent procedures and protocol requirements comply with applicable regulatory requirements
- Verify the integrity of data submitted on Case Report Forms and other data collection tools
- Monitor data for missing or implausible data
- Manage registries according to project plans and undertake feasibility work when requested
- Complete Serious Adverse Event reporting, reports, narratives, and follow-up
- Independently perform CRF review, query generation, and resolution using Fortrea or client data management systems
- Assist with training new employees through co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact
- Perform other duties assigned by management
- Travel frequently to client and site locations, including occasional domestic and international travel
Requirements:
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
- 5+ years of Clinical Monitoring experience
- Oncology experience; early phase preferred
- 30-50% overnight travel
- Comfortable working in a fast-paced environment with strict study protocol and timeline requirements
- Ability to adapt to constantly changing priorities
- Teamwork and people skills
- Ability to work in a technology-based electronic data environment
- Ability to sit for extended periods and operate a vehicle safely
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Occasional crouching, stooping, frequent bending and twisting of upper body and neck
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Light to moderate lifting and carrying objects including luggage and laptop computer, maximum 15-20 lbs
- Regular and consistent attendance
- Varied hours may be required
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