Clinical Trials Coordinator – Oncology Start-up

Lyell Immunopharma; Seattle (WA); On-site; USD 59,000 - 69,000; Full time

Benefits offered by this job

Equity Incentive Plan

Job summary

Lyell Immunopharma is seeking a Clinical Trial Support professional to assist in executing assigned study tasks and to help maintain TMF documentation across vendors. You will collaborate with the Clinical Operations team and cross-functional partners to ensure timely data collection and issue resolution.

The role requires familiarity with FDA regulations and ICH GCP guidelines, with preference for experience in oncology drug development and early-phase studies.

Qualifications

• BSc with 7+ years of experience required.
• MSc with 4+ years of experience required.

Responsibilities

• Conducts trial support activities as assigned, escalates issues and recommends solutions to address concerns.
• Supports drafting of study plans, process documents and creates forms as needed for efficient trial execution; collaborates with broader study team stakeholders to improve recommendations.
• Collects and collates data from CRO/vendors, as assigned by Manager, Clinical Trials or Associate, Clinical Trials Management, reports data to stakeholders as needed, raises any issues to study lead quickly for timely resolution.
• Tracks inputs and deliverables day-to-day in partnership with the Clinical Operations team; identifies ways to improve the way we track study progress, reaches out to cross-functional partners for follow up and pull through.
• Becomes subject matter expert in trial master file (TMF) requirements and conducts TMF review, reporting findings. Works with CRO and other vendors to support TMF maintenance by providing study documents when TMF resides with vendor.
• Learns and applies ICH GCP guidelines; stays current with evolving expectations and applies new protocols as required
• Tracks study expenses, as directed, tracks vendor or site invoices, routes invoices for

Skills

Cross-functional study delivery

Cross-functional teams

FDA regulations

ICH GCP guidelines

TMF knowledge

Vendor coordination

Education

BSc with 7+ years experience

MSc with 4+ years experience

Job description

Lyell Immunopharma is seeking a Clinical Trial Support professional to assist in executing assigned study tasks and to help maintain TMF documentation across vendors. You will collaborate with the Clinical Operations team and cross-functional partners to ensure timely data collection and issue resolution.

The role requires familiarity with FDA regulations and ICH GCP guidelines, with preference for experience in oncology drug development and early-phase studies.