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About the role
Key responsibilities & impact- Provide a high standard of care for participants in clinical trials and respond to emergency situations based on clinical research standards
- Conduct 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 enroll patients
- Verify informed consent procedures and protocol requirements comply with applicable regulations
- Ensure integrity of Case Report Form and other collected data through source-document monitoring
- Monitor data for missing or implausible information
- Manage registries according to project plans and undertake feasibility work when requested
- Complete Serious Adverse Event reporting, reports, narratives, and follow-up
- Perform CRF review and generate and resolve queries using Fortrea or client data management systems
- Assist with training new employees through activities such as co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator, with supervision if applicable
- Act as a local client contact when 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
- Oncology experience
- 60% overnight travel
- Comfortable working in a fast-paced, changing-priority, teamwork-oriented, technology-based environment
- Ability to sit for extended periods and operate a vehicle safely
- Repetitive hand movement of both hands and ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Occasional crouching and stooping, with frequent bending and twisting of upper body and neck
- Ability to access and use various in-house and off-the-shelf computer software
- Light to moderate lifting and carrying, including luggage and a laptop computer, up to 15–20 lbs
- Regular and consistent attendance
- Ability to work varied hours
Benefits
Comp & perks- Remote work arrangement
- Ongoing applications accepted
- EEO and accommodations support
