Principal CRA

CO

PRA Health Sciences

Req #: 112635
Type: Colombia
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PRA Health Sciences

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				Overview:

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

You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people's lives. Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.

Responsibilities:

What you will be doing:

* Maintain timelines. Ensure accuracy and completeness of data entered into systems.
* Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
* Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by the respective project manager. Help successfully implement study plans for specific phases of a trial.
* Slot into existing projects in order to identify potential problems and improve timelines.
* To independently and proactively co-ordinate and advise others on all the necessary activities required to set up and monitor a study, including the following:
 - Identify investigators.
- Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements.
 - Placement, pre- study and initiation visits.
- Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP/WP, as appropriate.
- Complete accurate study status reports.
- 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.
- Assume additional responsibilities as directed by the 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 required

Qualifications:

You are: 

* Bachelor's degree in a health, life sciences or other relevant field of study.
* Minimum 8 years' work experience of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
* Availability to travel is required.
* All employees must read, write and speak fluent English and host country language.

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.

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

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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, 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 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.
			
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