Senior Oncology CRA — Site Monitoring

SystImmune, Inc.; Redmond (WA); Sur place; USD 90 000 - 140 000; Plein temps

Avantages offerts par ce poste

Medical/dental/vision premiums paid

Short-term disability

Long-term disability

401(k) company match (50% up to 3%)

Vesting in 5 years

15 PTO days per year

Sick leave

11 paid holidays

Résumé du poste

SystImmune, Inc. in Redmond, WA seeks a Senior Clinical Research Associate (CRA) to manage trial sites, ensure data quality and patient safety per ICH‑GCP. The role requires independence, strong organization, and ability to adapt to changing project priorities within a small team.

The Sr CRA will lead site visits, assist in study plans, manage recruitment strategies, monitor data and safety, and maintain essential trial documents. Occasional travel is required.

Qualifications

• 5+ years monitoring Oncology trials with on-site and remote visits.
• Excellent verbal and written communication skills.
• Strong organizational, multi-tasking and time management abilities.
• Experience developing/maintaining site relationships and ensuring regulatory compliance.
• Working knowledge of ICH-GCP guidelines.
• Proficient in Microsoft Office and clinical trial systems (CTMS, EDC, eTMF).

Responsabilités

• Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits.
• Ensure investigator sites meet contractual and regulatory requirements for site initiation and first release of study drug.
• Assist in the collection of key documents to enable site activation timely.
• Assist in development of study/program plans and SOP updates as directed by the Clinical Project Manager.
• Manage patient recruitment strategies and address barriers to recruitment.
• Monitor recruitment, data quality and patient safety on-site and remotely via EDC.
• Liaise with study site personnel for timely data entry into eCRF and resolution of data queries.
• Maintain project files including ethics approvals, investigator CVs, and study documents.
• Identify and complete follow-up of SAEs at study sites.
• Ensure timely submission of documents to the Trial Master File.
• Perform IP inventory, reconciliation and ensure proper storage and security.

Connaissances

On-site monitoring

Remote monitoring

Verbal and written communication

Organizational skills

Multi-tasking

Time management

Site relationships and compliance

ICH-GCP knowledge

Microsoft Office & CTMS/EDC/eTMF

Formation

Bachelor’s degree in health science or related field

Outils

CTMS

EDC

eTMF

SharePoint/Teams

Description du poste

SystImmune, Inc. in Redmond, WA seeks a Senior Clinical Research Associate (CRA) to manage trial sites, ensure data quality and patient safety per ICH‑GCP. The role requires independence, strong organization, and ability to adapt to changing project priorities within a small team.

The Sr CRA will lead site visits, assist in study plans, manage recruitment strategies, monitor data and safety, and maintain essential trial documents. Occasional travel is required.