Site Management Associate II
Core
Administrative support and coordination for clinical trial sites, managing documentation, communications, and regulatory submissions.
Role type
Administrative Site Management Associate
Builds
Clinical trial administrative processes and documentation
Domain
Clinical Research / Life Sciences
Deliverable
Dashboards & analysis (TMF/ISF management) | Client delivery (site coordination)
Required skills
Regulatory document preparation, site audit coordination, EDC progress tracking, TMF management, ISF maintenance, translation coordination, IP-RED compilation, training organization, vendor/supply access management
Preferred skills
Coaching junior staff, investigator meeting organization
Technologies
MS Office Suite (Word, Excel, Outlook, PowerPoint), Trial Management Systems, Vendor systems
Responsibilities
Serve as main contact for non-trial participant issues; manage records flow; prepare regulatory/ethics documents; coordinate site payments; prepare for audits/inspections; review query resolution; track EDC completion; organize investigator meetings; file and check TMF/ISF; coordinate translation of trial records; compile IP-RED packages.
Seniority
Junior, supervised IC
