Freelance Senior CRA
Core
Coordinate activities to set up and monitor clinical studies in phases II–IV, ensuring adherence to regulations and ICH-GCP principles.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial sites and study monitoring activities for pharmaceutical/biotech clients
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
Monitoring experience in phase I-III trials, Knowledge of ICH-GCP guidelines, Medical data review and evaluation, Regulatory submission preparation, Feasibility study preparation, Study cost-effectiveness management, Training and mentoring junior CRAs
Preferred skills
Valid driving license, Ability to travel internationally and domestically (60%+ of time)
Technologies
None stated
Responsibilities
Identify, select, initiate, and close-out investigational sites; Submit protocols and consent documents for ethics/IRB approval; Balance sponsor queries and manage study costs; Assist in training and mentoring less expert CRAs
Seniority
Senior, hands-on IC
