JUMP TO CONTENT

Senior CRA

  1. Poland
2025-120880
  1. Clinical Monitoring
  2. ICON Strategic Solutions
  3. Home-Based

About the role

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


JOB OBJECTIVE

Maximizing site performance and site engagement in Sponsor conducted clinical studies. Leveraging strong clinical operational and therapeutic expertise (scientific, clinical, disease states, and treatment alternatives knowledge within the therapeutic area(s)) to support execution of the clinical studies.

Responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to ensure compliance with Sponsor's Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory requirements.  Engages with clinical sites to develop, build, and maintain strong relationships with investigators/staff that will ensure high quality investigative sites to support Sponsor's clinical development programs. Collaborate with internal and external stakeholders as well as third party vendors. Provide operational support to the CPM/Sr CPM to deliver the study within planned timelines and according to required standards of quality and compliance. Evaluate, screen and develop high quality investigative sites to support Sponsor clinical development programs

 

Responsibilities:

Site Engagement Deliverables:

  • Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the Sponsor Clinical Team and key internal stake holders throughout the life cycle of Sponsor clinical trials
  • Support Sponsor clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of Sponsor trials
  • Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of Sponsor and its activities thereby increasing their desire to partner with Sponsor
  • Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to Sponsor forums, boards and/or discussions
  • Interact/train new investigators to work on Sponsor clinical trials

 

Monitoring Deliverables:

  • Responsible for all kinds of site visits (e.g. Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites’ performance regarding set-up, conduct and data collection
  • Primary contact for sites regarding study-related issues.
  • Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study.
  • Interact/train new investigators to work on Sponsor clinical trials.
  • Attend key therapeutic trainings/meetings and/or industry trainings.
  • Support CPM in management of the study, including but not limited to:
  • Vendor management
  • Training
  • Logistics
  • Selection of sites
  • Maintenance of study tracking
  • Oversight of eTMF
  • Close cooperation with the Clinical Project Managers and members of the Clinical Trial Teams to inform on all aspects of the clinical trial status at site.
  • Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.
  • Support the development of key study documents including, but not limited to Case Report Form (CRFs), diaries, informed consent/participant information, the study concept and protocols/amendments including presentations and Investigator Meetings or other trial-related meetings.
  • Prepare and/or review monitoring tools, e.g. monitoring manual
  • Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials.
  • Review and approval of site regulatory packages
  • Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs.

Depending on trial setting:

  • Train appropriate internal and CRO personnel on trial-specific monitoring requirements.
  • Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data.
  • Conduct co-monitoring visits with internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.

 


  • A minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in site engagement or an investigator facing role (e.g. clinical project manager, study director/coordinator, clinical research associate, patient/site engagement companies)
  • S., M.S. degree in a life science/biological related field preferred. At least three years experience in monitoring of trials in clinical development environment, preferably in phase 2-4 if responsibility for phase 2-4.
  • Strong Knowledge of GCP and ICH Guidelines.

 

 

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others


Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.

 

#LI-DD1

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

Senior CRA

Salary

Location

Brazil

Department

Clinical Monitoring

Location

Brazil

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

A Clinical Research Associate is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You

Reference

2025-121293

Expiry date

01/01/0001

Bruna Duarte

Author

Bruna Duarte
Read more Shortlist Save this role
Study Start Up Associate I

Salary

Location

Brazil

Department

Clinical Monitoring

Location

Brazil

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

The Study Start Up Associate fulfills the role of Local Regulatory Affairs Lead (LRAL) and is responsible for preparing, submitting and following up on initial and amended Regulatory Agency (RA), Cent

Reference

2025-121261

Expiry date

01/01/0001

Bruna Duarte

Author

Bruna Duarte
Read more Shortlist Save this role
CRA II

Salary

Location

Brazil

Department

Clinical Monitoring

Location

Brazil

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

A Clinical Research Associate is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You

Reference

2025-120648

Expiry date

01/01/0001

Bruna Duarte

Author

Bruna Duarte
Read more Shortlist Save this role
CRA I

Salary

Location

Brazil

Department

Clinical Monitoring

Location

Brazil

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

A Clinical Research Associate is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You

Reference

2025-119352

Expiry date

01/01/0001

Bruna Duarte

Author

Bruna Duarte
Read more Shortlist Save this role
Clinical Research Associate - All Levels (São Paulo)

Salary

Location

Brazil

Department

Clinical Monitoring

Location

Brazil

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

A Clinical Research Associate is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You

Reference

2025-120986

Expiry date

01/01/0001

Bruna Duarte

Author

Bruna Duarte
Read more Shortlist Save this role
CRA II - Hematology

Salary

Location

Miami

Department

Clinical Monitoring

Location

Miami

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As a CRA you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence. We are currently looking for a CRA II with Hematology trials e

Reference

2025-121379

Expiry date

01/01/0001

Jamie Pruitt

Author

Jamie Pruitt
Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above