Central Clinical Research Associate
Core
Central Clinical Research Associate serving as the primary liaison for Principal Investigators and site staff to conduct rare disease registries, managing site selection, study start-up, remote and onsite monitoring, data quality, and regulatory compliance.
Role type
Senior IC Clinical Research Associate (Registries)
Builds
Rare disease registry studies for Specialty Care, Vaccines, and R&D functions
Domain
Life Sciences / Clinical Research / Rare Diseases
Required skills
ICH-GCP compliance, site monitoring (remote/onsite), study start-up management, data quality assurance, regulatory document preparation, patient recruitment support, stakeholder liaison, CAPA implementation
Preferred skills
Experience with electronic Trial Master File (eTMF), knowledge of Health Authority/Regulatory Authority submission processes, familiarity with rare disease registries
Technologies
eTMF, eCRF, clinical trial management systems
Responsibilities
Conduct remote and onsite site monitoring visits (Site Selection, Initiation, Routine, Close Out); manage study start-up activities including document collection, EC/IRB submissions, and contract support; review and resolve data queries to ensure data integrity; support patient recruitment and retention; ensure compliance with ICH-GCP and local regulations; coordinate with vendors and internal stakeholders.
Seniority
Mid-Senior, hands-on IC
