Exact Sciences is looking to solve the problem of changing how the world prevents, detects, and guides treatment for cancer by providing clarity to patients and clinicians for confident decision-making.
Requirements
- Proficiency in data management, including progressive experience in data entry, validation, and cleaning.
- Familiarity with Electronic Data Capture (EDC) systems.
- Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements.
- Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices.
- Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits.
- Proficiency in monitoring plans, protocol adherence, and GCP guidelines.
- Working knowledge of the FDA submission process including IDE, PMA, and 510(k).
Responsibilities
- Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies.
- Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships.
- Serve as a point of contact for investigators and site staff.
- Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates.
- Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables.
- Conduct thorough site qualifications visits.
- Conduct efficient and comprehensive site initiation visits.
Other
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to work designated schedule.
- Ability to work nights and/or weekends, as needed.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to travel 50% of working time away from work location, may include overnight/weekend travel.
