• Clinical Development
• Clinical Pharmacology
• Therapeutic Indications
• Consulting and Regulatory Services
• Enabling Technologies
• Full and Functional Service Provider Models

• Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support
• Assist in the preparation of study and site specific materials in accordance with relevant SOPs
• Complete minute taking and documentation for sponsor/external or internal teleconferences as requested
• Assist in setting up and maintaining tracking systems/spreadsheet for e.g. study supplies
• Maintain the Project Directory
• Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting
• Provide support to project team (e.g. proof-reading and editing correspondence, mailings, shipping of study files, faxing and photocopying documents, assembling study documents, and arranging meetings, etc.)
• Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable
• Audit and CAPA tracking
• Set up and maintain clinical investigator files and documentation
• Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members:
  • Coordinate and plan study supply shipments with vendors
  • Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery
  • Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e. diary cards, patient visit reminders);
• Generate reports as needed, for example CTMS site contact information list
• Work with the In-House CRA and other project team members on reconciliation of data with CTMS.
• General communications to sponsors, sites and internal team members via electronic mail or courier or telephone
• Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead

• Minimum Required:
  • Completion of at least 2 years of a Diploma – Associate degree or equivalent
  • Good oral and written communication skills
  • Good organizational and time management skills
  • Computer literacy (Microsoft Office Suite (Word, Excel, Power Point)

• Preferred:
  • Aptitude for handling and proof-reading numerical data, some spreadsheet software competency
  • Good typing skills
  • Good spelling and proof-reading skills
  • Ability to operate standard office equipment (e.g., fax, copier)
  • Works efficiently and effectively in a matrix environment