Study Start Up Specialist, Business Operations
Core
Drive clinical trial initiation by conducting feasibility assessments, identifying sites, negotiating contracts, and ensuring regulatory compliance for study start-up activities.
Role type
Senior IC clinical trial study start-up specialist
Builds
Clinical trial sites and study initiation plans
Domain
Clinical research / Pharmaceutical
Required skills
Feasibility assessment, site identification, contract negotiation, regulatory submission coordination, informed consent form review
Preferred skills
Medical or science background, experience with sponsor-dedicated models
Technologies
Clinical trial management systems, regulatory databases
Responsibilities
Conduct feasibility assessments and site identification; Negotiate site contracts; Prepare and coordinate regulatory and ethics submissions; Review and finalize Subject Information Sheets and Informed Consent Forms
Seniority
Mid-level, hands-on IC
