Essential Job Duties:
1) Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support
2) Assist in the preparation of study and site specific materials in accordance with relevant SOPs
3) Complete minute taking and documentation for sponsor/external or internal teleconferences as requested
4) Assist in setting up and maintaining tracking systems/spreadsheet for e.g. study supplies
5) Maintain the Project Directory
6) Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting
7) 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.)
8) Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive
as applicable
9) Audit and CAPA tracking
10) Set up and maintain clinical investigator files and documentation
11) 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).
12) Generate reports as needed, for example CTMS site contact information list
13) Work with the In-House CRA and other project team members on reconciliation of data with CTMS.
14) General communications to sponsors, sites and internal team members via electronic mail or courier or telephone
15) Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead.
Requirement:
•Minimum one (I) year administrative experience or equivalent training
•Good oral and written communication skills
•Good organizational and time management skills
•Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint)
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
• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
• Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
• Thorough knowledge of monitoring procedures
• Basic understanding of the clinical trial process
• Valid Driver's License