Clinical Study Administrator
- Poland
- Corporate Support
- ICON Strategic Solutions
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please click here to view live vacancies.
The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives
- Assists in coordination and administration of clinical studies from the start-up to execution and close- out.
- Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
- Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
- Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
- Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
- Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
- Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
- Contributes to the production and maintenance of study documents, ensuring template and version compliance.
- Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.
#LI-MC6
#LI-Remote
- High school qualification
- Previous administrative experience
- Good knowledge of spoken and written English
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. Learn more about Our Culture at ICON
Day in the life
Teaser label
Inside ICONContent type
BlogsPublish date
06/23/2020
Summary
“Leadership is a choice; it is not a rank." In a recent TedTalk, leadership expert Simon Sinek discussed the ideal behavioral traits that came with being a good leader. Not only is it essential
Teaser label
Inside ICONContent type
BlogsPublish date
06/12/2020
Summary
Though digital interviews are relatively new to the recruitment scene, the shift to remote working has seen an unprecedented surge in demand and usage. In 2019, companies were increasingly adopt
Teaser label
Inside ICONContent type
BlogsPublish date
01/28/2015
Summary
ICON began its journey to international success from humble beginnings in Ireland in 1990. Started by Dr John Climax and Dr Ronan Lambe, the first office had five team members and since then has
Similar jobs at ICON
Salary
Location
Ireland, Dublin
Department
Full Service - Corporate Support
Location
Dublin
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Marketing & Media
Communications
Job Type
Permanent
Description
ICON plc is hiring a Head of Global Corporate Communications to drive our global Communications, Reputation Management and Corporate Social Responsibility strategies.This is a hands-on leadership role
Reference
JR138501
Expiry date
01/01/0001
Author
Caroline LockAuthor
Caroline LockSalary
Location
Ireland, Dublin
Department
Full Service - Corporate Support
Location
Dublin
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Accounting & Finance
Job Type
Permanent
Description
Our GBS Business Partnering Group sits within the Corporate Finance arm of ICON Finance. This role is aimed at providing independent, objective, financial and consulting services designed to add value
Reference
JR137044
Expiry date
01/01/0001
Author
Damien KehirAuthor
Damien KehirSalary
Location
Regional United States (PRA)
Location
Multiple US Locations
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Corporate Support
Job Type
Permanent
Description
Responsible for the successful negotiation and on-going maintenance of clinical trial agreements, complex amendments, and other ancillary agreements with investigative sites.Job Description *Drafts, r
Reference
JR136752
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon PupekSalary
Location
Brazil, Sao Paulo
Location
Sao Paulo
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Accounting & Finance
Job Type
Permanent
Description
We are currently seeking a Grant Specialist to join our dedicated team. As a Grant Specialist, you will play a vital role in managing the grant application process, ensuring compliance with funding re
Reference
JR138104
Expiry date
01/01/0001
Author
Bruna DuarteAuthor
Bruna DuarteSalary
Location
Czech Republic, Prague
Location
Prague
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Corporate Support
Job Type
Permanent
Description
We are currently seeking a Contract Analyst II to join our diverse and dynamic team. As a Contract Analyst II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpre
Reference
JR138052
Expiry date
01/01/0001
Author
Jaroslav PolákAuthor
Jaroslav PolákSalary
Location
Ireland, Dublin
Department
Full Service - Corporate Support
Location
Dublin
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Accounting & Finance
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization.We are currently seeking a Senior Manager or Manager for Commercial Finance to join our Global Commercial Finance
Reference
JR136789
Expiry date
01/01/0001
Author
Sophie ClarkeAuthor
Sophie Clarke