Clinical Research Associate II/ Senior Clinical Research Associate
Core
Ensuring quality, integrity, and compliance of clinical trials across various therapeutic indications by acting as the main communication point between trial sites and project teams.
Role type
Senior Clinical Research Associate
Builds
Clinical trial operations and data integrity
Domain
Clinical research / Life sciences
Deliverable
physical/clinical work
Required skills
Source data verification, Investigational product accountability, ICH-GCP guidelines knowledge, Site selection and initiation, Routine monitoring, Close-out visits, Patient recruitment monitoring, Trial supply management, ISF and TMF maintenance, Regulatory submission support, Audit preparation, Mentoring junior CRAs
Preferred skills
Oncology study experience
Technologies
Microsoft Office
Responsibilities
Conducting all types of monitoring visits (site selection, initiation, routine, close-out), Performing source data verification and managing data queries, Overseeing investigational product accountability, Maintaining Investigator Site Files and supporting TMF reconciliation, Delivering study-specific training to site staff, Supporting regulatory submissions and audit resolutions, Mentoring less experienced Clinical Research Associates
Seniority
Senior, hands-on IC