FSP项目外派***Global Pharm
Candidates familiar with VBA or other automation technical skills (such as Power Apps, Power Automate, Python, etc)
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.
61 Coordinate and plan study supply shipments with vendors
61 Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery
61 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:
61Minimum one (I) year administrative experience or equivalent training
61Good oral and written communication skills
61Good organizational and time management skills
61Computer literacy (Microsoft Office Suite (Word, Excel, PowerPoint)
Preferred:
61Aptitude for handling and proof-reading numerical data, some spreadsheet software competency
61Good typing skills
61Good spelling and proof-reading skills
61Ability to operate standard office equipment (e.g., fax, copier)
61Works efficiently and effectively in a matrix environment
61 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.
61 Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements
61 Thorough knowledge of monitoring procedures
61 Basic understanding of the clinical trial process
61 Valid Driver's License