该职位来源于猎聘 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
- 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.
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