Role : Clinical Research Coordinator

Location : Onsite - Santa Rosa, CA 95403

• Relocation candidates will NOT be considered for this position
• Role is 100% onsite, there will not be an opportunity for remote/hybrid work

Therapeutic Area : Oncology

Employment Type : Position is a contract, project based support role - current contract duration is estimated to be 3-5 months, possibility for extension

Schedule/ Shift:

• 30 hours a week, M-F during daytime business hours (8-5)
• Weekly schedule is TBD, open to reviewing candidates' preferences

Responsibilities/ Job Duties:

This candidate will work closely with all research staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization and Good Clinical Practices.

Responsibilities -

• May be the sole coordinator or work in collaboration with a research nurse on studies, responsible for source documents, data collection, data entry, query resolution, triggering financial payments, study close out and liaison with the sponsor/CRO
• Collects, verifies, organizes and records clinical information and data in electronic data capture systems EDC.
• Abstracts data from necessary sources to complete the EDC and resolve queries.
• Performs the following data related activities: EDC tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding

Minimum Education and Experience Qualification Requirements:

• Minimum 2 years experience with clinical trial coordination required
• Minimum 3 years experience working in oncology
• Strong EDC data entry / query resolution experience
• Experience with Medidata preferred, not required