Clinical Study Assistant
- Turkey
- Clinical Trial Support
- ICON Strategic Solutions
About the role
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
What you will be doing:
Providing clinical trial administration support to LTM/CDC TMs and all CRAs in Turkey
- Oversight of all trial documentation for assigned clinical trial, covering all involved adjacent affiliates within the CDC
- CTA documentation to support affiliates in HA and EC submissions - Ensure overview of local requirements
- TMF handling and archiving
- Timely uploading of trial documentation in electronic filing system
- Compliance check of electronic filing system, Ensure timely and adequate archiving at closeout
- Providing Investigator Trial Master Files (ITMFs) set-up and core input
- Supporting and tracking trial related payments (e.g. Investigator fees), including invoice processing
- Organisation of local meetings
- Supporting local safety reporting to PIs and HAs as relevant
- Supporting clinical supplies management and tracking all relevant processes
- Super User as relevant (e.g. electronic filing system)
You are:
- A minimum of 1-year clinical operations experience, preferably within the pharmaceutical or biotechnology industry
- Basic knowledge and understanding of Essential Documents, CFR and/or GCP/ICH
- Fluently in English
- Proficiency with technological systems (Microsoft Office, Excel, PowerPoint, SharePoint Online, eTMF and CTM.
- Fundamental understanding of filing systems and organizational tools
- BS/BA or equivalent preferred, or relevant and qualifying training/experience
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Inside ICONContent type
BlogsPublish date
01/26/2023
Summary
The CRO market has seen an unmistakable uplift in demand for its services in recent years. The call for personalised medicine, pricing pressures, and increasing complexity in clinical trials are j
Teaser label
Inside ICONContent type
BlogsPublish date
10/03/2022
Summary
In traditional clinical trials, patients must attend regular check-ins at hospitals or clinics but fully remote decentralised clinical trials (DCTs) and hybrid trials limit this by replacing the in-pe
Teaser label
Inside ICONContent type
BlogsPublish date
05/22/2022
Summary
Having enjoyed steady growth over the last several years, it’s predicted that the global clinical trials market will hit a value of $65.2 billion by 2025, and around 58% of this can be attributed to r
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