CRA II
TA Business Partner
About the role
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Clinical Research Associate I~II
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Working within a highly qualified team our Clinical Research Associates (CRA's) identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV ensuring adherence to applicable regulations and principles of ICH-GCP.
Overview of the Role
- Working independently and proactively to coordinate all necessary activities required for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation. - You will be involved in the submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested.
- Managing sponsor generated queries efficiently and taking responsibility for study cost effectiveness; you will also participate in the preparation and review of study documentation and feasibility studies
for new proposals as required.
- Depending on your level of experience, you may assist in training and mentoring less experienced
CRA's and/or manage CRA's working on international projects.
Role Requirements
- With a University degree in medicine, science, or equivalent; you will have at least 1+ year of previous monitoring experience in medium sized studies, including SIV and close-out (for all roles above Entry Level). You should also have knowledge of ICG GCP guidelines and the expertise to review and evaluate medical data.
- Good command of English, as well as the local language, you will possess excellent written and verbal communication and interpersonal skills enabling you to deal with queries in a timely manner.
- You should be able to produce accurate work to tight deadlines within a pressurised environment.
- You must be available to travel at least 60% of the time.
You will have the opportunity to progress your career and may wish to move into Project Management or into other related areas where you can further develop your skill set.
Benefits of Working in ICON :
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.
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
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