JUMP TO CONTENT

Study Start-Up CRA

  1. Argentina
2025-119542
  1. Clinical Monitoring
  2. ICON Strategic Solutions
  3. Home-Based

About the role

As a Study Start-Up CRA (SSU CRA) will be responsible of creating and endorsing submission packages related to the country or site, following ICH, GCP, and all relevant regulations, laws, guidelines, and ethical standards, within specific deadlines and quality standards, if applicable (depending on the country). Responsible for examining and endorsing critical documents at the site level for site activation, in accordance with regulatory/sponsor requirements, within specific deadlines and quality standards.


Main activities

 

• Perform feasibility, site identification, and other study start up activities, as assigned.

• Prepare, review and submit submissions to ethics and regulatory and other relevant authorities or agencies (if required) in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.

• Develop and finalize Country Specific ICFs (if applicable for country).

• Prepare and finalize Country Specific xml files (if applicable for region).

• Perform independent quality review of submission packages. 

• Collect and maintain (or have oversight if applicable) current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned countries and update relevant ICON or client information system.

• Responsible for the coordination of translations for documents required for submission (if applicable for country).

• Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system in collaboration with the CTAs (if applicable for country).

• Route incoming correspondence, internal documentation, etc., as appropriate.

• Responsible for the timely follow-up for queries made by EC and CA (if applicable for country).

• Responsible for the review and approval of critical documents required for site activation and IP Release, as appropriate.

• Attend study team meetings as required.

• Be familiar with ICH GCP, relevant country regulations/guidelines and ICON/client SOPs.

• Assist and provide support to the RCTM to maximize submission effectiveness, minimize timelines and ensure sponsor satisfaction.

• Undertake other reasonably related duties as may be assigned from time to time

 


Requisitions

 

• Bachelor’s degree in a health, life sciences or medical fields.
• Experience with study start-up activities and on-site monitoring experience. 
• Availability to travel when required.
• Fluent English and Spanish (read, write and speak)

• Based in Ciudad de Buenos Aires / Buenos Aires. 

 

Why ICON?

 

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

 

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

 

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

 

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

 

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

List #1

Day in the life

A picture of Debora Oh
How to excel as a CRA in a Clinical Research Organisation

Teaser label

Our People

Content type

Blogs

Publish date

08/29/2023

Summary

To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her

Teaser label

Brazil-based CRA II Debora Oh shares her tips on how to become a great CRA and provides insight into life at ICON.

Read more
A picture of Yemi Moses
Progressing as a CRA with ICON

Teaser label

Our People

Content type

Blogs

Publish date

05/23/2023

Summary

How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to excell

Teaser label

 Senior CRA Yemi Moses recounts her development and shares her career ambitions with ICON plc.

Read more
A picture of Suzaita
Suzaita's story - an insight into working in Clinical Research

Teaser label

A Day In The Life

Content type

Blogs

Publish date

04/05/2023

Summary

Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?

Teaser label

Senior Clinical Research Associate, Suzaita Hipolito, talks about how working in Clinical Research gives her happiness and fulfilment.

Read more
Suzaita Hipolito

by

Suzaita Hipolito

Suzaita Hipolito

by

Suzaita Hipolito

View all

Similar jobs at ICON

CRA II / Senior CRA Biotech

Salary

Location

Netherlands, Utrecht, Zen

Department

Clinical Monitoring

Real World Solutions

Location

Utrecht

Remote Working

Home or Office

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical

Reference

JR132526

Expiry date

01/01/0001

Sophie Clarke

Author

Sophie Clarke
Read more Shortlist Save this role
CRA II / Senior CRA (Large Pharma)

Salary

Location

Netherlands, Utrecht, Zen

Department

Clinical Monitoring

Location

Utrecht

Remote Working

Home or Office

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical

Reference

JR132524

Expiry date

01/01/0001

Sophie Clarke

Author

Sophie Clarke
Read more Shortlist Save this role
Clinical Research Associate

Salary

Location

South Africa

Department

Clinical Monitoring

Location

South Africa

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

Job Title: Clinical Research Associate (CRA) Location: Cape Town, South Africa Company: ICON Strategic Solutions – FSP

Reference

2025-120691

Expiry date

01/01/0001

Shelley Ball

Author

Shelley Ball
Read more Shortlist Save this role
CRA II / Senior CRA (Biotech)

Salary

Location

Belgium, Mechelen

Department

Clinical Monitoring

Real World Solutions

Location

Mechelen

Remote Working

Home or Office

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical

Reference

JR132521

Expiry date

01/01/0001

Sophie Clarke

Author

Sophie Clarke
Read more Shortlist Save this role
Senior CRA

Salary

Location

Netherlands

Department

Clinical Monitoring

Location

Netherlands

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

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

Reference

2025-120674

Expiry date

01/01/0001

Iris Brouwer

Author

Iris Brouwer
Read more Shortlist Save this role
CRA II

Salary

Location

Netherlands

Department

Clinical Monitoring

Location

Netherlands

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

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

Reference

2025-120528

Expiry date

01/01/0001

Iris Brouwer

Author

Iris Brouwer
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above