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.
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.
Excellent written and verbal communication in English.
Ability to produce accurate work to tight deadlines within a pressurized environment.
Willingness to travel at least 60% of the time (international and domestic -fly and drive) and 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.
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.
Our benefits examples include:
Various annual leave entitlements.
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
Life assurance.
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit ourcareers siteto 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.
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 or submit a requesthere .
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.
Are you a current ICON Employee? Please clickhereto apply.#J-18808-Ljbffr