Clinical Research Associate II
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
Clinical Research Associate II
Builds
Clinical trial data and regulatory submissions for rare disease and oncology therapies
Domain
Clinical research / Pharmacovigilance / Rare disease and Oncology
Deliverable
client delivery
Required skills
Extensive on-site monitoring experience in Phase 2/3 trials, ability to verify investigator qualifications and resources, training investigational site staff, regulatory submission preparation support
Preferred skills
Experience with complex trials (oncology, rare disease)
Technologies
None stated
Responsibilities
Perform Pre-Study, Initiation, Interim, and Close-Out monitoring visits; Identify and verify investigator qualifications, resources, facilities, equipment, and staff; Train investigational site staff as necessary; Support preparation of regulatory and/or EC submissions
Seniority
Mid-level IC