JUMP TO CONTENT

Clinical Study Administrator

  1. Poland
2025-119912
  1. Corporate Support
  2. ICON Strategic Solutions
  3. Remote

About the role

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  

List #1

Day in the life

A picture of two people, one is writing. There are a pair of glasses at the front of the picture
How to promote leadership in your team

Teaser label

Inside ICON

Content type

Blogs

Publish 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 to va

Teaser label

“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.

Read more
A picture of two people speaking to someone over video chat on a laptop
Digital interviewing: How ICON is increasing hiring flexibility

Teaser label

Inside ICON

Content type

Blogs

Publish 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 adopting th

Teaser label

Though digital interviews are relatively new to the recruitment scene, the shift to remote working has seen an unprecedented surge in demand and usage.

Read more
A picture of Genalyn
What drives your excellence?

Teaser label

Inclusion & Belonging

Content type

Blogs

Publish date

06/02/2015

Summary

ICON has been providing outsourced development services on a global scale to the pharmaceutical, biotechnological and medical device industries for 25 years. Employing over 10,000 employees across 38

Teaser label

ICON has been providing outsourced development services on a global scale to the pharmaceutical, biotechnological and medical device industries for 25 years.

Read more
View all

Similar jobs at ICON

Senior Manager - Financial Reporting - Fluent Spanish

Salary

Location

Ireland, Dublin

Department

Full Service - Corporate Support

Location

Dublin

Business Area

ICON Full Service & Corporate Support

Job Categories

Accounting & Finance

Job Type

Permanent

Description

ICON Plc has an excellent opportunity for a fluent Spanish speaking qualified accounting professional which will involve working on a broad range of domestic and cross border accounting issues across

Reference

JR131306

Expiry date

01/01/0001

Damien Kehir

Author

Damien Kehir
Read more Shortlist Save this role
Director, Finance

Salary

Location

India, Chennai

Department

Full Service - Corporate Support

Location

Chennai

Business Area

ICON Full Service & Corporate Support

Job Categories

Accounting & Finance

Job Type

Permanent

Description

We are currently seeking a Director, Finance to join our diverse and dynamic team. Project Finance group provides financial and consulting services designed to add value, direction and leadership to t

Reference

JR130618

Expiry date

01/01/0001

Read more Shortlist Save this role
Financial Analyst II - FBP

Salary

Location

India, Chennai

Department

Full Service - Corporate Support

Location

Chennai

Business Area

ICON Full Service & Corporate Support

Job Categories

Accounting & Finance

Job Type

Permanent

Description

The Role We are looking for a candidate who can Build Report & Analyse financial results to leaders in the context of each Business unit objective.This person is also responsible for Owing P &L, Forec

Reference

JR130437

Expiry date

01/01/0001

Puja Jaiswal

Author

Puja Jaiswal
Read more Shortlist Save this role
Account Payable Associate - Credit Cards

Salary

Location

India, Chennai

Location

Chennai

Business Area

ICON Full Service & Corporate Support

Job Categories

Accounting & Finance

Job Type

Permanent

Description

We are currently seeking an Accounts Payable Associate to join our diverse and dynamic team. As an Accounts Payable Associate at ICON, you will play a pivotal role in managing financial transactions,

Reference

JR130184

Expiry date

01/01/0001

Rathinam Lakshmipathy Read more Shortlist Save this role
Manager, Finance

Salary

Location

India, Chennai

Location

Chennai

Trivandrum

Business Area

ICON Full Service & Corporate Support

Job Categories

Accounting & Finance

Job Type

Permanent

Description

We are currently seeking a Manager, Finance to join our diverse and dynamic team. The finance business partnering (“FBP”) group provides financial and consulting services designed to add value, direct

Reference

JR129954

Expiry date

01/01/0001

Puja Jaiswal

Author

Puja Jaiswal
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above