Description
We are seeking a proactive and detail-oriented Clinical Trial Administrator to join our team in Norway.
As a Clinical Trial Administrator, you will be an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project.
Summary of Responsibilities:
- 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/spreadsheets 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.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- Diploma – Associate degree or equivalent.
- In lieu of the above requirement, candidates with 1-2 or more years of relevant Clinical Research experience in pharmaceutical or CRO industries may be considered.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Speaking English and local language (fluent).
- Writing/Reading English and local language (fluent).
Experience (Minimum Required):
- 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)).
- 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.