CRA II/Sr CRA - Oncology

This is a fully remote position, open to applicants in Oregon.

📋 Description

• Conduct site qualification, initiation, interim monitoring, management, and closure visits, either on-site or remotely.

• Ensure adherence to regulatory standards, ICH-GCP/GPP guidelines, and study protocols.

• Assess the performance of sites and staff, developing or escalating action plans as necessary.

• Confirm informed consent, prioritize subject/patient safety, and maintain the integrity of clinical data.

• Evaluate site processes and perform source document and medical record reviews.

• Validate clinical data in case report forms and ensure resolution of queries.

• Assist with clinical study data review, data capture, and compliance with electronic data capture standards.

• Oversee the inventory, reconciliation, storage, dispensing, and administration reviews of investigational products.

• Review Investigator Site Files and ensure they align with Trial Master Files.

• Record monitoring activities through letters, trip reports, communication logs, and project documentation.

• Aid in subject/patient recruitment, retention, and awareness initiatives.

• Monitor observations, status updates, and action items until resolution.

• Manage site-level activities and communications aligned with project scope, budgets, timelines, and deliverables.

• Collaborate with study site personnel and provide training to assigned site/project team members.

• Participate in investigator meetings, sponsor meetings, global project meetings, and clinical training sessions.

• Assist in audit readiness, preparation, and follow-up actions.

• For Real World Late Phase, support sites throughout the study lifecycle, conduct chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities, and recommend potential sites.

⛳️ Requirements

• A Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other pertinent regulatory requirements.

• Proficient computer skills and a willingness to adapt to new technologies.

• Strong communication, presentation, and interpersonal skills.

• Willingness to travel up to 75% regularly.

• Must fulfill site requests for medical and other personal information necessary for facility access as a condition of employment.

• For Real World Late Phase: understanding of local requirements for real world late phase study designs.

• For Real World Late Phase: experience or knowledge in chart abstraction activities and data collection.

• For Real World Late Phase: experience in collaborating with Sponsor affiliates, medical science liaisons, and local country staff.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and comprehensive rewards program.

• Company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company match for 401k contributions.

• Eligibility for commissions/bonuses based on individual and company performance.

• Flexible paid time off (PTO).

• Sick time.