Senior Clinical Research Associate
Core
Conduct site monitoring, initiation, and close-out visits for clinical studies in various therapeutic areas to ensure data quality and regulatory compliance.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data and regulatory submissions for pharmaceutical clients
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Site monitoring, source document verification, CRF review, query resolution, site selection, feasibility assessment, regulatory document preparation, audit/inspection participation
Preferred skills
Oncology/Hematology/Gastroenterology/Infectious Diseases/Neurology/Renal therapeutic area experience, Phase II/III trial experience
Technologies
MS Word, Excel, PowerPoint
Responsibilities
Prepare and conduct site selection, initiation, routine monitoring, and close-out visits; Perform CRF review and source document verification; Manage site communication and act as liaison between project teams and sites; Lead project team calls at country level; Ensure subject recruitment targets and project timelines are met; Participate in feasibility research and site audits/inspections
Seniority
Senior, hands-on IC