CRA II
- Spain
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
Team Lead
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
As a Clinical Research Associate (CRA) you will be dedicated to one of our global Healthcare clients who have a strong legacy of innovation and leading the way within a specialist therapeutic area. They display an ongoing commitment to changing the lives of patients and the accessibility of products in order to change the lives of those that need them.
The CRA is the primary point of contact between site staff and sponsor. This CRA will be responsible for taking leadership of site management for the selection and initiation of sites on behalf of the sponsor, as well as conducting and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, sponsor´s procedures and protocol requirements.
What you will be doing:
- Perform all type of visits from site feasibility to close out visits according to plan, document actions and follow up on action plans
- Train and guide site staff in safety information handling, systems, protocol and trial procedures to minimize protocol deviations
- Proactive use of EDC and other data source systems for preparation and conduct on site visits as well as source data verification in collaboration with data management/logistics team
- Identify potential risks and proactively take action to prevent or mitigate
- Collaborate with Data Management/logistics in resolving queries
- Assist to ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
- Motivate and build strong relations with site personnel to assist the sponsor in being their preferred clinical research partner
- Collaborate with and provide oversight of deliverables from vendors locally, if applicable
- Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
- Participate in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
- Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
- Support audits and inspections at sites and affiliate, as applicable
You are:
- Bachelor or Master’s degree in life sciences or other relevant fields.
- At least 2-3 years of experience as a Clinical Research Associate.
- Therapeutic area knowledge and demonstrating an understanding of oncology (solid tumors) phase I studies is an advantage.
- Excellent knowledge of Clinical Trial Management Systems, Good Clinical Practices and Trial Management.
- Strong analytical and communication skills with business, industry understanding and stakeholder management.
- Fluent in both Spanish and English.
- Valid driver’s license
Why 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.
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.
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
![A picture of Debora Oh](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2811/img/Oi_Ywfaw1E2c5AjadgdpUA/75/debora-oh-thumbnail.jpg)
Teaser label
Our PeopleContent type
BlogsPublish 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
![A picture of Yemi Moses](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2811/img/voIjKGzvOUdxWAjadgXIBA/75/yemi-moses-thumbnail.jpg)
Teaser label
Our PeopleContent type
BlogsPublish 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
![A picture of Suzaita](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2811/img/x7o-Djy2R0cv_gjbLGx6Ig/75/Suzaita.png)
Teaser label
A Day In The LifeContent type
BlogsPublish 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?
by
Suzaita Hipolito
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