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About the role
Key responsibilities & impact- Perform all aspects of study site monitoring, including routine monitoring and close-out of clinical sites
- Maintain study files and conduct pre-study and initiation visits
- Liaise with vendors and manage sites according to project plans
- Ensure study staff receive proper materials and instructions
- Verify informed consent procedures and protocol compliance
- Monitor source documents and data for missing or implausible information
- Manage clinical study registries and undertake feasibility work
- Complete Serious Adverse Event reporting, narratives, and follow-up
- Perform CRF review and 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
- Act as a local client contact when assigned
- Perform other duties assigned by management
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, constantly changing, technology-based environment
- Teamwork and people skills
- Ability to sit for extended periods and operate a vehicle safely
- Repetitive hand movement of both hands with ability to make fast, simple, repeated movements of fingers, hands, and wrists
- Occasional crouching and stooping, with frequent bending and twisting of upper body and neck
- Ability to access and use a variety of computer software developed in-house and off-the-shelf
- Ability to lift and carry 15–20 lbs
- Regular and consistent attendance
- Varied hours may be required
Benefits
Comp & perks- Remote work arrangement with a mix of onsite and remote work
- Ongoing applications accepted
- EEO and accommodations support
