Clinical Trial Support Specialist with Financial Acumen
2 weeks ago
As a Clinical Trial Assistant with Financial expertise, you will play a vital role in supporting our study budgets and ensuring financial accuracy for our clinical trials at Fortrea Denmark ApS.
Key Responsibilities
- Track and document study activities using specialized tools and Project Management Systems.
- 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.
Requirements
Prior experience in a similar role (medical secretary/administrator, accountant) is required. Clinical research experience is a plus, but not mandatory.
Prior experience in hospital contracts, budget preparation, vendor management, and invoicing are highly desirable.
Proficiency in Microsoft Office and comfortable utilizing different systems.
Excellent written and verbal communication skills in Danish and English are essential.
Exceptional organizational and time management skills, allowing you to prioritize effectively.
A “can-do” attitude, a thirst for knowledge, and a willingness to apply your skills in a new environment.
Fortrea Denmark ApS is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
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