Senior In-House Clinical Research Associate
Core
Senior In-House Clinical Research Associate supporting day-to-day execution of clinical trial activities, site management, and vendor coordination for oncology trials.
Role type
Senior In-House Clinical Research Associate
Builds
Clinical trial operations and execution for oncology therapeutics
Domain
Biotechnology / Oncology / Clinical Trials
Deliverable
client delivery
Required skills
Clinical trial management, Site management, Vendor management, Trial Master File management, ICH-GCP knowledge, Data review, Protocol deviation review, Study documentation development
Preferred skills
Cross-trial process improvement, Mentoring junior team members
Technologies
Study tracking tools
Responsibilities
Assist with completion of assigned project delivery and clinical trial operational tasks in compliance with ICH-GCP, applicable SOPs, and protocols; Support site management and monitoring activities including site selection, activation, investigational product management, and contract management; Assist with day-to-day vendor management activities including contract tracking, change order management, and invoice review; Contribute to the development, maintenance, and quality control of trial documentation including study manuals, plans, protocols, and the Trial Master File; Assist with data review, protocol deviation review, and the query process; Help onboard and guide new or junior team members.
Seniority
Senior, hands-on IC