Site Management Associate I
Core
Ensures exchange of information and documentation with clinical sites and vendors, manages inventory of clinical supplies, and coordinates site audits and inspections.
Role type
Site Management Associate I
Builds
Clinical trial site operations and vendor supply chains
Domain
Clinical research / Medical device trials
Deliverable
client delivery
Required skills
Regulatory submission management, inventory reconciliation, audit coordination, query resolution, EDC completion tracking, safety information flow, CTMS data management, vendor facility testing coordination, document management (TMF/ISF), training coordination
Preferred skills
MS Office proficiency, typing skills (40 wpm), knowledge of project-specific systems
Responsibilities
Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies; Coordinates preparation for and follow-up on site, TMF and systems audits and inspections; Updates CTMS with project information and tracks resolution status of site issues; Arranges and tracks initial and ongoing project training for site teams; Checks TMF regularly and files pending documents; Ensures proper safety information flow with investigative sites.
Seniority
Entry-level to Junior, hands-on IC
