Senior CRA

Senior CRA - Malaysia, Kuala Lumpur

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

Opening: Clinical Research Associate (Malaysia IPH, JR113645)

Country: Malaysia

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

With our patients at the centre 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.

The Role:

• Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP

• Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate.

• Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.

What you will be doing:

As a Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to 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. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

The Role

• Working independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation

• Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested

• Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required

• Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness

• Dependent on level of experience you may assist in training and mentoring less expert CRA’s and/or lead CRA’s working on international projects

To be successful in the role, you will have:

• 18 months+ of monitoring experience in phase I-III trials as a CRA

• Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data

• You will possess excellent written and verbal communication in English

• Ability to produce accurate work to tight deadlines within a pressurized environment

• You will be asked to travel at least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license

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 through the form below.

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

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.

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