Help us change livesAt Exact Sciences, we're helpingchange how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.Position OverviewThis position is responsible for executing, managing and conducting projects associated with the company clinical study plans. The Senior Clinical Research Associate I (CLRA) is responsible for site management deliverables on assigned protocols and may act as a lead CRA for the study, providing guidance and support to other CRAs on the team.This position is field based / remote and must be located in the West Coast region. This is including but not limited to CA, AZ, WA, and OR.Essential DutiesInclude, but are not limited to, the following: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.Support the Clinical Study Manager to develop study-specific training materials.Conduct thorough site qualifications visits. Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams.Conduct efficient and comprehensive site initiation visits. Ensure all assigned site staff are trained appropriately, have access to required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements.Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs. Maintain a flexible monitoring schedule (as appropriate) and assists in co-monitoring or monitoring support of clinical sites/studies.Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements). Ensure all clinical site staff actively participating in the study are appropriately trained. Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team.Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team. Assist clinical site in resolving issues, if appropriate.Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicate status of Site management activities on a routine basis to the Clinical Project team and management.Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and in-house and regional CRA team members.Assist with the creation of protocol, CRFs, and all other associated study documents.Support the Clinical Study Manager to develop, implement and execute, the clinical study Monitoring Plan. Ensure compliance with the plan and all assigned tasks throughout the study.Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit rep