Teams at Maplight Therapeutics

The Senior Clinical Research Associate manages investigator sites and conducts pre-study, initiation, interim, and closeout monitoring visits. Responsibilities include centralized and risk-based monitoring, ensuring subject safety, data integrity, protocol compliance, inspection readiness, and accurate trial documentation. The role collaborates with clinical operations, medical monitoring, data management, quality, CROs, and vendors, while supporting clinical systems, study documents, monitoring plans, and process improvements. Up to 75% travel is required.

Conducts on-site and centralized monitoring of clinical trial investigator sites from study start-up through closeout. Ensures subject safety, data integrity, protocol compliance, inspection readiness, and adherence to ICH GCP and company SOPs. Manages site relationships, monitoring documentation, risks, action items, and study milestones while collaborating with internal teams, CROs, and vendors. Supports clinical systems, monitoring plans, study documents, audits, and process improvements.

Support clinical operations across all trial phases: manage TMF and study documents, coordinate systems access, liaise with sites/CROs/vendors, prepare meeting materials and minutes, maintain trackers, assist with clinical trial insurance and data review, and ensure compliance with SOPs and ICH-GCP.