Site Management Associate
Core
Key support to clinical research projects by streamlining communication, maintaining systems, and managing documents and information for investigative sites and vendors.
Role type
Site Management Associate (Clinical Research Operations)
Builds
Clinical research operations support for medical science projects
Domain
Clinical Research / Pharmaceutical Industry
Deliverable
client delivery
Required skills
Data exchange and document management, Clinical supply inventory and reconciliation, Regulatory and ethics committee submission coordination, Audit and inspection preparation support, Meeting organization and minute taking, Trial Master File (TMF) maintenance, Investigator Site File (ISF) preparation and oversight, Safety information flow management
Preferred skills
Administrative experience, MS Office proficiency, Translation status checking
Technologies
Trial Master File (TMF), Investigator Site Files (ISF), Corporate tracking systems
Responsibilities
Exchange project data and documents between sites, vendors, and the project team; Ensure order, receipt, storage, distribution, and reconciliation of clinical supplies; Administer site and vendor payments; Coordinate regulatory and ethics committee submissions; Prepare for and follow up on site, TMF, and systems audits; Support organization of internal team meetings and Investigator's Meetings; Maintain and review Trial Master Files (TMF) and Investigator Site Files (ISF); Ensure proper safety information flow with investigative sites.
Seniority
Individual Contributor, Support Level
