Clinical Research Associate
Core
Monitors patient data and study-related information at clinical trial sites to ensure adherence to protocols, regulatory requirements, and Good Clinical Practices.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and site compliance
Domain
Pharmaceutical industry / Clinical Research
Required skills
Clinical trial monitoring, Site initiation and closeout, Protocol compliance, Risk-based monitoring, Patient data validation, Regulatory knowledge (ICH/GCP/FDA/EMA), Site training and development
Preferred skills
Pharmaceutical industry experience, Central/in-house monitoring experience, Drug development process knowledge, Therapeutic knowledge
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Conduct onsite and remote site monitoring, Perform site initiation and closeout visits, Ensure site personnel training on trial aspects, Identify and mitigate site process deficiencies, Collaborate with study teams on patient recruitment and data quality, Promote compliance culture and ethical integrity
Seniority
Entry to Mid-level
