Clinical Trial Operations Specialist

Planet Pharma; Seattle (WA); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Planet Pharma is seeking a Clinical Operations professional to support day-to-day management of outsourced clinical trials. The role ensures study conduct aligns with the protocol, ICH-GCP, and applicable regulatory requirements while supporting TMF, site coordination, and vendor communications.

The successful candidate will assist in study-start up, monitor recruitment, and help manage audits and quality assurance activities, working with cross-functional teams across CROs and investigator

Qualifications

• Experience operating in a clinical environment and with clinical protocols.
• Familiarity with ICH-GCP guidelines and regulatory requirements.
• Strong organizational and documentation skills.

Responsabilités

• Develop and distribute meeting agendas, minutes and monthly status reports to stakeholders.
• Support trial management in communications with CROs, vendors and sites.
• Assist start-up activities and review essential study documents and contracts.
• Track subject recruitment and monitor visits, updates and protocol deviations.
• Maintain TMF documentation and coordinate with IWRS, EDC and CTMS systems.
• Participate in audits/inspections and communicate findings.
• Support cross-functional study team interactions and other duties as assigned.

Connaissances

Clinical trial operations

Regulatory compliance

Communication skills

GCP knowledge

Formation

Bachelor of Science in Biomedical Sciences

Outils

IWRS

EDC

CTMS

Description du poste

Planet Pharma is seeking a Clinical Operations professional to support day-to-day management of outsourced clinical trials. The role ensures study conduct aligns with the protocol, ICH-GCP, and applicable regulatory requirements while supporting TMF, site coordination, and vendor communications.

The successful candidate will assist in study-start up, monitor recruitment, and help manage audits and quality assurance activities, working with cross-functional teams across CROs and investigator