Clinical Research Associate (CRA) - Freelance
Core
Freelance Clinical Research Associate supporting the DED PET study for Alzheimer's prevention and cognitive function research at BBRC.
Role type
Freelance Clinical Research Associate (CRA)
Builds
Clinical trial monitoring and data integrity for a neurodegenerative disease research project
Domain
Biomedical research / Alzheimer's disease / Clinical trials
Deliverable
client delivery
Required skills
Clinical trial monitoring, Site start-up and close-out management, eCRF and source data verification, Informed consent review, Query and deviation management, CAPA management, TMF management, Regulatory compliance (GCP), Training material creation
Preferred skills
Autonomous work, Calendar planning, Attention to detail, Risk anticipation
Technologies
eCRF, TMF
Responsibilities
Participate in site start-up activities including essential document review; Develop and execute study monitoring plans; Conduct monitoring visits at participating centers to ensure protocol and GCP compliance; Review informed consent forms and investigator documentation; Verify data in eCRF and source documents for consistency and completeness; Manage deviations, queries, and CAPAs; Prepare monitoring reports and associated documentation; Support TMF management; Participate in sponsor meetings and regulatory audits; Create study training materials for participating centers
