Senior Oncology CRA — West Coast (On-site/Remote)

SystImmune, Inc.; United States; Remote; USD 110,000 - 145,000; Full time

Benefits offered by this job

Premium medical/dental/vision

401(k) with company match

PTO & holidays

Job summary

SystImmune, Inc. in Redmond, WA and Princeton, NJ is seeking a Senior Clinical Research Associate (CRA) to oversee clinical trial sites, ensuring data quality and patient safety in line with ICH-GCP guidelines.

The role requires 5+ years of oncology trial monitoring, strong communication and organization, and willingness to travel 50-75%. You will coordinate with CROs, manage regulatory documents, and support study start-up and close-out activities.

Qualifications

• 5+ years monitoring Oncology trials independently conducting on-site & remote monitoring visits.
• Excellent verbal and written communication skills required.
• Excellent organizational, multi-tasking and time management skills required.

Responsibilities

• Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits.
• Prepare the study reference manual, including liaising with the CRO team to ensure efficient preparation and delivery of study materials to investigator sites.
• Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug.
• Assist in the development of study/program plans (Monitoring Plan, eCRF Guidelines, Data Management Plan, Safety Management Plan).
• Manage patient recruitment strategies and identify barriers to recruitment, proposing solutions.

Skills

Oncology trial monitoring

Site management

Communication skills

Organizational skills

Multi-tasking

Travel readiness

CTMS/EDC familiarity

Education

Bachelor’s degree in health science or related field

Tools

CTMS

EDC

eTMF

Microsoft Office

SharePoint

Teams

Job description

SystImmune, Inc. in Redmond, WA and Princeton, NJ is seeking a Senior Clinical Research Associate (CRA) to oversee clinical trial sites, ensuring data quality and patient safety in line with ICH-GCP guidelines.

The role requires 5+ years of oncology trial monitoring, strong communication and organization, and willingness to travel 50-75%. You will coordinate with CROs, manage regulatory documents, and support study start-up and close-out activities.