Clinical Research Associate II
Core
Monitors clinical study activities to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols.
Role type
Mid-level Clinical Research Associate (CRA)
Builds
Clinical trials for hypercortisolism, oncology, ALS, and liver disease
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
GCP compliance, clinical trial process knowledge, medical terminology, drug supply coordination, protocol development, vendor management, site monitoring
Preferred skills
Therapeutic area knowledge, study budget negotiation, RFP creation, informed consent drafting, cross-functional collaboration
Technologies
Clinical trial management systems, computer applications for data tracking
Responsibilities
Supervise study and site preparation, coordinate cross-functional trial components, negotiate clinical trial agreements and budgets, produce RFPs and evaluate vendor bids, draft informed consent forms, develop study documents (CRFs, manuals), monitor clinical sites in the field, track essential trial documents, report on CRO and site performance
Seniority
Mid-level, hands-on IC