Clinical Research Coordinator III
Core
Oversee and manage clinical operations at a research site, ensuring compliance with study protocols and regulatory guidelines, providing training and support to staff, and serving as a liaison between the site and clinical trial sponsors.
Role type
Senior Clinical Research Coordinator (Site Management)
Builds
Clinical trial operations and patient enrollment
Domain
Clinical research / Pharmaceutical Product Development
Required skills
Clinical study management, Regulatory compliance (FDA/GCP/ICH), Patient safety monitoring, Protocol adherence, Data collection and documentation, IRB management, Team leadership and mentoring, Scheduling and capacity management, Adverse event reporting, Informed consent processes
Preferred skills
Negotiation and influencing, Complex problem solving, Discretion and sound judgement, Computer proficiency, Interpersonal skills
Technologies
Computer generated forms, Clinical trial software, Basic computer applications
Responsibilities
Conduct clinical studies according to FDA/GCP and ICH regulations, Schedule subject visits within protocol windows, Perform study activities including vital signs, pregnancy tests, ECGs, and blood samples, Record patient information and results on required forms, Ensure IRB approval is obtained and requirements are met, Monitor safety and well-being of study participants, Serve as primary point of contact for sponsors, Oversee and assign work to team members, Assist in hiring and training new team members
Seniority
Senior, hands-on IC with leadership duties