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Site Management Associate I

2 months ago

King of Prussia, Pennsylvania, United States PSI CRO Full time

Company Description

PSI is a leading Contract Research Organization with almost 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

Site Management

  • Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team
  • Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
  • Supports CA submissions and notifications
  • Assists with handling administrative financial tasks
  • Coordinates preparation for and follow-up on site, TMF and systems ́ audits and inspections

Other Communication

  • Exchanges data, documents, and other information with the project team and other departments
  • Provides assistance with organization of internal team meetings
  • Prepares draft minutes of internal team meetings
  • Assists with preparation, attendance and follow-up of Investigator's Meetings, as applicable
  • Under supervision, maintains study-specific and corporate tracking systems

Document Management

  • Maintains Trial Master File (TMF)
  • Perform TMF review and oversight at country and site level
  • Prepares, distributes, and updates Onsite Study Files (OSF) and OSF checklists
  • Provides assistance with translations

Safety Management

  • Ensures proper safety information flow with investigative sites

Other Assistance

  • Provides miscellaneous administrative project support (if applicable)

Qualifications

College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.

  • Basic proficiency in MS Word
  • Basic proficiency in MS Excel
  • Basic proficiency in MS Outlook
  • Basic proficiency in MS Power Point
  • Basic proficiency in Skype for Business
  • Knowledge (following proper training) of applicable software and project specific systems
  • Basic typing skills in English (min. 40 words per minute)

Additional Information

All your information will be kept confidential according to EEO guidelines.