Senior Clinical Research Associate – Oncology, FSP

This is a fully remote position, open to applicants in Oregon, +1 more state.

📋 Description

• Oversee site management, monitoring, and closure for assigned investigator sites.

• Ensure that clinical trials adhere to monitoring plans, relevant laws, GCP, and sponsor standards.

• Manage trial activities from the activation of sites through to database lock.

• Act as the primary liaison for the assigned investigator sites.

• Facilitate communication among study teams, vendors, and sites.

• Coach and train site personnel while providing protocol education.

• Assist with enrollment and initiatives for site-level recruitment.

• Conduct both onsite and remote/electronic monitoring for site initiation, routine monitoring, and closure.

• Monitor adverse events and serious adverse events, ensuring follow-up with investigators.

• Submit documentation for the Trial Master File, including site reports, follow-up letters, protocol deviations, recruitment updates, supply management, progress, and metrics.

• Identify and address site issues while developing corrective and preventive actions.

• Resolve data queries and carry out site close-out activities.

• Supervise the receipt, handling, accounting, storage, and destruction of investigational products.

• Support database release and assume unblinded monitoring responsibilities as needed.

• Maintain knowledge of product, protocol, and therapy-area specifics.

• Ensure patient safety, eligibility, and provide clinical guidance.

• Lead Quality Event remediation and audit CAPA activities when necessary.

• Collaborate with Site Care Partners, Country Study Operations Managers, clinicians, recruitment specialists, and clinical data scientists.

• May provide mentorship to Clinical Research Associates.

⛳️ Requirements

• At least 3 years of relevant experience in clinical research site monitoring.

• Ideally, 2 years of experience in oncology.

• Clinical research experience within a CRO or pharmaceutical company.

• Global clinical trial experience is preferred.

• Extensive understanding of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• Proficient in English and in the native language(s) of the country of work.

• A valid driver’s license and passport are required.

• Familiarity with clinical research and development processes.

• Knowledge of global and local regulatory requirements.

• Understanding of monitoring, data acquisition and cleaning, and reporting.

• Awareness of disease and technical areas relevant to clinical studies.

• Capability to support sponsor regulatory interactions and inspections.

• Knowledge of protocol design and feasibility assessment.

• Understanding of regional/country culture and medical practices.

• Ability to work effectively within a matrix team environment and influence or lead through others.

• Capacity to evaluate, interpret, and present complex issues and data.

• Strong verbal and written communication skills.

• Bachelor’s degree in life sciences or an equivalent professional degree, such as nursing, pharmacy, or medicine.

🏝️ Benefits

• Equal opportunity employer.

• Global clinical research organization environment.

• Opportunity to contribute to therapies that benefit patients.

• Collaboration with global clinical, regulatory, therapeutic, and consulting professionals.