JUMP TO CONTENT
Shortlist
search jobs Search
About the role ICON and you Application Process Day in the life Who we are

CRA I

047039_2

About the role

This vacancy has now expired. Please see similar roles below...

 
  
Identify, select, initiate, and close-out appropriate investigational sites for clinical studies.  Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP.  Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate.  Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
 
Overview of the Role
  • Travel (approximately 60%) domestic and/or international
  • Expert knowledge of ICON Clinical Research SOPs/WPs, ICH, GCP and appropriate regulations.
  • Expert knowledgeable of ICON systems.
  • Maintain timelines.  Ensure accuracy and completeness of data entered into ICON systems.
  • Recruitment of investigators.
  • Independent and proactive co-ordination of all the necessary activities required to set up and monitor a study, including the following:
    • Identify investigators.
    • Help, when requested, in preparation of regulatory submissions.
    • Design patient information sheets and consent forms.
    • Co-ordinate documents translation, verification and back translations where required.
    • Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements.
    • Pre Study/placement and initiation visits.
    • Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP, as appropriate.
    • Maintain all files and documentation pertaining to studies.
    • Motivate investigators in order to achieve recruitment targets.
    • Complete accurate study status reports.
    • Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
    • Keep the project manager or designees regularly informed.
    • Process case record forms to the required quality standards and timelines.
    • Deal with sponsor generated queries in a timely manner.
    • Ensure the satisfactory close-out of investigator sites.
    • Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
    • Ensure correct archiving of files on completion of a study.
    • Maintain patient and sponsor confidentiality.
    • Assume additional responsibilities as directed by Project Manager (PM).
    • Responsible for the conduct/management of any aspect(s) of a project, when requested and authorized by a Project Manager.
    • Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.
    • Co-ordinate and/or participate in feasibility studies for new proposals, as require
  • Investigational Products (IPs) stored and managed by the site:
    • Ensure storage conditions and acceptable supplies are provided
    • Ensure IPs is supplied only to eligible patients.
    • Ensure IP receipt, use and return are controlled and documented.
    • Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.
  • Be cost effective.
  • Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
  • Participate in data listing reviews, as applicable.
  • Assist with marketing the company if and when appropriate.
  • Other duties as assigned.
Role Requirements / Skills / Experience Required
  • Bachelor’s degree or equivalent in medicine, science or related discipline.
  • Experience should include monitoring skills and understanding of field monitoring requirements 
  • Minimum of 18 months experience as a CRA I 
  • Ability to review and evaluate clinical data.
  • Computer literacy desirable
  • Good oral and written communication skills.
List #1

Day in the life

Mission, vision, Values
Home Sweet Office: Why Culture Compatibility Matters

Teaser label

Inclusion & Belonging

Content type

Blogs

Publish date

04/29/2024

Summary

Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how

Teaser label

Explore how aligning with the right company culture can transform your work environment into a home away from home.

Read more
Medicine container
Precision Medicine: How Personalised Therapies are Transforming Healthcare

Teaser label

Industry

Content type

Blogs

Publish date

04/29/2024

Summary

Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi

Teaser label

Discover how precision medicine is revolutionising healthcare by tailoring treatments to each patient.

Read more
Headshot of Deepak, the author of this blog
Day in the life of a Clinical Data Mangement Project Manager

Teaser label

Our People

Content type

Blogs

Publish date

04/29/2024

Summary

Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o

Teaser label

Deepak shares his experience as Clinical Data Management Project Manager at ICON Strategic Solutions.

Read more
View all

Who we are

Press play to find out more

Similar jobs at ICON

Global Study Associate

Salary

Location

Shanghai

Department

Clinical Monitoring

Location

Shanghai

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a Global Study Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Global Study Associate Shanghai Office based

Reference

2024-110204

Expiry date

01/01/0001

Read more Shortlist Save this role
Read more Shortlist Save this role
Global Study Associate Manager

Salary

Location

Shanghai

Department

Clinical Monitoring

Location

Shanghai

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a Global Study Associate Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Global Study Associate Manager Shang

Reference

2024-110203

Expiry date

01/01/0001

Read more Shortlist Save this role
Read more Shortlist Save this role
Clinical Supplies Project Manager

Salary

Location

Mexico, Mexico City

Department

Drug Safety & Pharmacovigilence

Location

Mexico City

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Project Management

Clinical Supplies

Job Type

Permanent

Description

​Clinical Supplies Project ManagerICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced s

Reference

JR116640

Expiry date

01/01/0001

Elizabeth Davies

Author

Elizabeth Davies
Elizabeth Davies

Author

Elizabeth Davies
Read more Shortlist Save this role
Read more Shortlist Save this role
Principal Biostatistician

Salary

Location

Ireland, Europe, United Kingdom, South Africa, Poland, Bulgaria, Spain, Germany, Netherlands, Romania, Czech Republic, Slovakia

Department

Biometrics Roles

Location

Any EMEA Location

Bulgaria

Czech Republic

Germany

Ireland

Netherlands

Poland

Romania

South Africa

Spain

UK

Slovakia

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Statistics

Job Type

Permanent

Description

As a Principal Biostatistician you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2023-104906

Expiry date

01/01/0001

Read more Shortlist Save this role
Read more Shortlist Save this role
Senior CRA

Salary

Location

Argentina

Department

Clinical Monitoring

Location

Argentina

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.  A CRA is a professional who cont

Reference

2023-103904

Expiry date

01/01/0001

Tulio Sanquiz

Author

Tulio Sanquiz
Tulio Sanquiz

Author

Tulio Sanquiz
Read more Shortlist Save this role
Read more Shortlist Save this role
Clinical Trial Manager

Salary

Location

Argentina

Department

Clinical Trial Management

Location

Argentina

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Management

Job Type

Permanent

Description

As a Clinical Trial Manager you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.

Reference

2023-103323

Expiry date

01/01/0001

Tulio Sanquiz

Author

Tulio Sanquiz
Tulio Sanquiz

Author

Tulio Sanquiz
Read more Shortlist Save this role
Read more Shortlist Save this role

Browse popular job categories below or search all jobs above