Study Start Up Associate I
Core
Facilitate the initiation of clinical trials by preparing regulatory documents, coordinating approvals, and supporting study team development of protocols and consent forms.
Role type
Junior clinical research associate (site start-up)
Builds
Clinical trial sites and regulatory submissions for pharmaceutical sponsors
Domain
Clinical research / Regulatory affairs
Required skills
Regulatory document preparation, stakeholder coordination, record maintenance, study document development, meeting participation
Preferred skills
Clinical research experience, regulatory affairs experience
Technologies
Clinical trial applications, ethics committee submission systems
Responsibilities
Prepare and submit regulatory documents (clinical trial applications, ethics committee submissions), coordinate with stakeholders for study initiation approvals, maintain records of submissions and approvals, support development of study documents (protocols, informed consent forms, investigator brochures), participate in study start-up meetings
Seniority
Entry-level, individual contributor
