Senior Clinical Research Associate - FSP Melbourne / Sydney
Core
Senior Clinical Research Associate responsible for site monitoring, site management, and leading small clinical projects for pharmaceutical or CRO clients.
Role type
Senior Clinical Research Associate (Site Monitoring & Management)
Builds
Clinical trials data integrity and regulatory compliance at study sites
Domain
Clinical Research / Pharmaceutical Development
Deliverable
client delivery
Required skills
Clinical site monitoring, study site management, registry administration, SAE reporting, protocol development, CRF review, vendor liaison, investigator recruitment, budget negotiation, regulatory compliance knowledge, data quality assurance
Preferred skills
Life science degree, nursing or medical certification, experience in matrix environments, training and mentoring junior staff
Technologies
Clinical trial data management systems, computer packages
Responsibilities
Conduct routine and closeout monitoring visits, ensure informed consent and protocol adherence, review source documents and CRFs for data integrity, manage clinical trial supplies and vendors, organize investigator meetings, track Serious Adverse Events, assist in protocol and report writing, coordinate local project activities, mentor junior staff
Seniority
Senior, hands-on IC with line management responsibilities
