Senior Clinical Research Associate
Core
Independently manage clinical aspects of small to medium-sized studies or assume significant management responsibilities on large-scale studies to ensure compliance with protocol and GCPs.
Role type
Senior Clinical Research Associate (Sponsor)
Builds
Clinical studies for hypercortisolism, oncology, ALS, and liver disease treatments
Domain
Biopharmaceuticals / Clinical Operations
Required skills
Clinical study management, GCP/ICH regulations, Protocol development, Site monitoring, Vendor management, Regulatory file maintenance, Budget negotiation, Study timeline management
Preferred skills
Pharmaceutical industry experience, Medical terminology, Scientific literature review, Data quality assurance, Team leadership
Technologies
Microsoft Office, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC)
Responsibilities
Conduct sponsor oversight, site qualification, and initiation visits; Develop study processes, workflows, and resource plans; Review study designs and site implementation tactics; Liaise with CMC team for drug supply monitoring; Participate in CRO/Vendor RFP reviews and bid defenses; Maintain regulatory files and Trial Master Files (TMF); Evaluate clinical study reports for accuracy and trends.
Seniority
Senior, hands-on IC with management responsibilities
