Clinical Research Associate II / Senior CRA
Core
Conduct on-site or remote monitoring visits (Pre-Study, Initiation, Interim, Close-Out) to ensure investigational sites and staff are adequate for clinical study conduct.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data quality and regulatory compliance for rare disease and oncology studies
Domain
Clinical Research / Biopharmaceuticals (Rare Disease, Oncology)
Deliverable
client delivery
Required skills
Phase 2/3 trial monitoring, complex trial management, investigator qualification verification, site training, regulatory submission support
Preferred skills
Oncology or rare disease trial experience
Technologies
None stated
Responsibilities
Perform on-site or remote monitoring visits to verify site adequacy; Identify and verify investigator qualifications, resources, and staff; Train investigational site staff as necessary; Support preparation of regulatory or EC submissions
Seniority
Senior, hands-on IC
