Clinical Trials Coordinator
2 meses atrás
As a key member of our Clinical Project Team, the Clinical Trial Assistant will play a vital role in the execution of clinical research projects. The level of responsibility will be commensurate with the individual's experience and ability to contribute to the project's success.
Key Responsibilities- Communicate with project team members regarding study updates and maintain documentation as required by protocols, SOPs, and regulatory standards.
- Ensure timely production of high-quality clinical data and provide systems support.
- Track information related to the status of study activities and assist with general administrative functions as required.
- Complete minute-taking and documentation for sponsor/external or internal teleconferences as requested.
- Assist in setting up and maintaining tracking systems/spreadsheets for study supplies.
- Maintain the Project Directory and provide support for Investigator Meetings.
- Provide support to project team members, including proof-reading and editing correspondence, mailings, shipping of study files, faxing, and photocopying documents.
- Maintain Trial Master File documentation within the appropriate TMF platform and participate in TMF QC, as assigned.
- Audit and CAPA tracking.
- Set up and maintain clinical investigator files and documentation.
- Liaise with vendors, as needed, for study conduct.
- Coordinate and plan study supply shipments with vendors.
- Maintain and confirm shipment information, including courier tracking numbers and date of shipping and delivery.
- Prepare and assemble study supplies for sites, including Study File Notebooks, CRFs, and other study-specific ancillary supplies.
- Generate reports as needed, such as CTMS site contact information lists.
- Work with the In-House CRA and other project team members on reconciliation of data with CTMS.
- Perform other administrative duties as assigned by Line Manager, Project Managers, or Clinical Trial Lead.
- Diploma or Associate degree or equivalent.
- Relevant Clinical Research experience in pharmaceutical or CRO industries may be considered in lieu of educational requirements.
- Language Skills: Speaking and writing in English and local language.
- Minimum one year of administrative experience or equivalent training.
- Good oral and written communication skills.
- Good organizational and time management skills.
- Computer literacy in Microsoft Office Suite (Word, Excel, PowerPoint).
Fortrea is a global contract research organization dedicated to revolutionizing the development process. We are seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our collaborative workspace fosters personal growth, enabling you to make a meaningful global impact.
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