Clinical Trial Operations Specialist

Planet Pharma; Seattle (WA); On-site; USD 55,000 - 73,000; Full time

Job summary

Planet Pharma in Seattle is seeking a qualified professional to support day-to-day clinical study activities. The role involves assisting the clinical operations project team to plan, execute, and close outsourced trials while ensuring compliance with protocol, ICH GCP, and regulatory requirements.

Responsibilities include creating meeting agendas and status reports, supporting start-up documents, tracking recruitment and site visits, maintaining TMF, and coordinating with CROs, vendors and

Qualifications

• Requires a BSc in biomedical sciences with 2 years clinical research experience.
• Experience conducting or supporting clinical trial activities.
• Familiarity with ICH GCP guidelines is preferred.

Responsibilities

• Develop and distribute meeting agendas, minutes, and monthly status reports to stakeholders.
• Support start-up activities and review study-related documents (Monitoring Plan, Lab Manual, etc.).
• Track recruitment, visits, approvals, infringements, deviations; notify CRO/site updates.
• Assist in filing site essential documents and TMF; track supplies with IWRS/EDC/CTMS.
• Follow ICH GCP guidelines and coordinate audits/inspections; support QA activities.
• Participate in regular team meetings and Investigator Meetings as needed.
• Escalate out-of-scope issues to the Clinical Trial Manager.
• Support cross-functional study team communication.
• Other duties as assigned.

Skills

Clinical environment experience

Experience with clinical protocols

Education

BSc in Biomedical Sciences

Job description

Planet Pharma in Seattle is seeking a qualified professional to support day-to-day clinical study activities. The role involves assisting the clinical operations project team to plan, execute, and close outsourced trials while ensuring compliance with protocol, ICH GCP, and regulatory requirements.

Responsibilities include creating meeting agendas and status reports, supporting start-up documents, tracking recruitment and site visits, maintaining TMF, and coordinating with CROs, vendors and