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FSP Clinical Research Associate 2 – Oncology, Non-Oncology
Fortrea. Provide a high standard of care for participants in clinical trials and respond to emergency situations according to clinical research standards .
About the role
Key responsibilities & impact- Provide a high standard of care for participants in clinical trials and respond to emergency situations according to 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
- Verify informed consent procedures and protocol requirements comply with applicable regulations
- 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
- Undertake feasibility work when requested
- Complete Serious Adverse Event reporting, reports, narratives, and follow-up
- Perform CRF review, query generation, and query resolution in Fortrea or client data management systems
- Assist with training new employees through co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator
- Act as a local client contact as assigned
- Perform other duties assigned by management
- Travel frequently to client and site locations, including occasional domestic and international travel
Requirements
What you’ll need- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
- 2 years of Clinical Monitoring experience
- 60% overnight travel
- Comfortable working in a fast-paced environment with strict study-protocol timelines
- 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, fingers, hands, and wrists
- Ability to crouch, stoop, bend, and twist the upper body and neck
- Ability to access and use in-house and off-the-shelf computer software
- Ability to lift and carry 15–20 lbs
- Regular and consistent attendance
- Ability to work varied hours
Benefits
Comp & perks- Remote work arrangement
- 8–10 days on site per month with a mix of onsite and remote work
- Ongoing applications accepted