Study Start Up Associate Ii

hace 2 semanas

San Vicente Ferrer, Colombia ICON A tiempo completo

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

As a Study Start Up Associate II at ICON, you’ll work within a large-scale, fast-paced environment assisting the Study Start Up Team Lead in the development of the plan for country and site distribution and execution of SSU activities in assigned countries. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

**The Role**
- Development and Authoring of study level informed consent masters in accordance with client specific requirement
- Liaising with ICON and sponsor study teams where required
- Review and approval of country and site level informed consent in accordance with client specific requirements
- Ensuring any legal or sponsor mandatory text requirements are adhered to
- Liaising with ICON and sponsor teams where required
- Provide guidance and leadership to the study team in relation to Informed Consent process and development
- Ensuring timely review and tracking of consents to meet established study timeline and required metrics
- Involvement in the development of sponsor and ICON specific guidance and training

**What you need**
- Native English speaker or very high verbal and written English skills
- Strong team and customer liaison skills
- Knowledge of the basic elements required to construct Informed Consents
- Preparing and negotiating acceptable informed consents
- A bachelor's degree in any of the Life Sciences, Nursing and/or Pharmacy with experience in a research or healthcare setting
- 3 years' experience and/or equivalent competencies in pharmaceutical industry/clinical research including a working knowledge of the clinical/regulatory development process

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.

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