Senior Clinical Research Associate
Core
Monitor and own the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and regulations.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trials across various therapeutic areas
Domain
Clinical research / Pharmaceutical / Biotechnology / Medical device
Required skills
Clinical trial monitoring, Regulatory compliance (ICH-GCP), Site management, Risk identification and mitigation, Conflict resolution, Financial management (for Senior CRAs), Study startup activities
Preferred skills
Graduate or postgraduate degree in scientific/healthcare discipline, Experience in financial management
Technologies
ICH-GCP, SOPs
Responsibilities
Monitor clinical studies at investigative sites, Coordinate study setup activities (identify investigators, prepare regulatory submissions, conduct pre-study and initiation visits), Train and mentor junior staff, Interact directly with clients, Participate in proposal activities and client presentations
Seniority
Senior, hands-on IC with mentorship responsibilities