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Clinical Research Associate II

  1. Brazil
2024-115290
  1. Clinical Monitoring
  2. ICON Strategic Solutions
  3. Remote

About the role

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 will be joining a program takes an extensive co-monitoring approach that enables a supportive and collaborative work environment. Frequent, consistent communication, both internally and with our client, positions our program to be closely aligned on our shared goals.


The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and all applicable regulatory requirements.

 

• Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel and study close out.
• Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in
accordance to applicable regulations.
• Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable
regulations and SOPs.
• Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.
• Verifies proper management and accountability of Investigational Product (IP).
• Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed
deficiencies, issues, and corrective and preventative action plans as appropriate.
• Manages essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study; assists with resolution of investigational site/data queries.
• Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
• Participates in audit preparation and follow-up activities as needed.

• Independently performs a variety of onsite and offsite monitoring visit types.
• Gathers and reviews information for assigned siteand identifies inconsistencies. With limitedguidance from project and
functional management, assesses risk and escalatesas appropriate.
• Assists with non-complex adhoc, short-term assignmentin support of additional studies or departmental initiatives.
• May serve as preceptor, providing training to less experienced clinical team members.


• Undergraduate degree or international equivalent in clinical, science, or healthrelated field from an accredited institution; health care professional licensure, i.e., registered nurse

• Previous experience supporting clinical trials including solid on-site monitoring experience.

• Travel is required 50-80%

* Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.




Benefits of Working in ICON:

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, color, 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.

 

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.

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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 exce

Teaser label

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

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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.

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Suzaita Hipolito

by

Suzaita Hipolito

Suzaita Hipolito

by

Suzaita Hipolito

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