Informed Consent Specialist II
Core
Lead the development, review, and oversight of informed consent documents (ICFs) for complex, global clinical trials.
Role type
Senior Informed Consent Specialist (Clinical Research)
Builds
Global and local informed consent forms aligned with protocol and regulatory requirements
Domain
Clinical research / Healthcare / Regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Informed consent strategy, GCP knowledge, regulatory compliance, translation oversight, stakeholder management, training and mentorship
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead creation and optimization of global/local ICFs; Advise study teams on consent strategy and country-specific considerations; Oversee translation processes and version control; Interface with sponsors, ethics committees, and regulatory bodies; Develop guidance templates and best practices; Provide training and mentorship to junior team members
Seniority
Senior, hands-on IC
