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Clinical Document Specialist I
4 months ago
**Clinical Document Specialist I - Leeds or Remote, UK**:
Are you looking for a fresh start within a clinical document environment? Interested in working within Clinical Pharmacology, working alongside our Project Management and Phase I Monitoring team, in an administrative and IT-focused opportunity?
Fortrea is seeking a Clinical Document Specialist to join the global Clinical Pharmacology Services team. Perhaps you have some experience within a medical/life sciences environment but now looking to be home-based, managing documentation compliance across the clinical trial process.
**The position can be office-based/hybrid in Leeds, or can be home-office based, within the UK.**
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
**Key Responsibilities**:
Your main responsibilities will include but not be restricted to:
- Responsible for general maintenance and any required archival of documents produced by the study project teams within CPS.
- Organizing, gathering, scanning, and filing of all applicable documents into appropriate electronic and/or paper copy locations, including the Trial Master File (TMF), as directed by Fortrea SOPs or other applicable directive.
- Responsible for document query generation and file reconciliation/resolution activities to support delivery of the TMF to client quality and integrity specifications, as well as to meet project timelines and productivity targets.
- Maintains an internal standardized filing structure for study-related documents.
- Works directly with the assigned Study Project Manager (PM) to review and finalise the TMF Plan and Index for individual projects.
- Creates and/or maintains any general document/file-related tracking forms and/or spreadsheets, as applicable.
- Maintains the TMF by working with applicable project team members to retrieve, file, and upload documents in accordance with applicable SOPs, policies, system, and client requirements.
- May interact directly with project teams in securing documents for the TMF, as appropriate.
- May interact directly with project teams to follow up regarding missing documents, as appropriate.
- Performs archiving duties for all paper and/or electronic media, as needed.
- Maintains departmental files including, but not limited to, project files.
**Experience**:
- Any experience within an administrative or IT-focused role within clinical trials or a hospital/medical setting would be advantageous. Full training will be provided.
- Experience working with computers and basic programs (i.e., Adobe Acrobat, Word, Excel, PowerPoint).
**Education / Qualifications**:
- High School Diploma or equivalent.
- Strong written and verbal communication skills (English language).
- Strong organisational skills, with the ability to work in a fast-paced setting with many interruptions.
**Did you know?**:
**#LI-Remote, **Remote
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