CRA I

Opening: Clinical Research Associate (CRA) II (Malaysia)

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:

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.

• Independent, proactive work to set up and monitor studies, complete reports and maintain documentation

• Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions

• Balancing sponsor generated queries

• Taking responsibility for study cost efficiency

• Preparation and review of study documentation and feasibility studies for new proposals

• Potential to assist in training and mentoring fellow CRAs

What you will be doing:

• Recognize, exemplify and adhere to ICONs values which centre on our commitment to People, Clients and Performance.

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

• Ability and willingness to travel at least 60% of the time (international and domestic : fly and drive)

• Expert knowledge of ICON's SOPs/WPs, ICH, GCP and appropriate regulations.

• Familiarity with ICON systems

• Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.

• Recruitment of investigators.

• Independent and proactive coordination of all the necessary activities required to set up and monitor a study, including but not limited to the following:

o Identify investigators.

o Help when requested, in preparation of regulatory submissions. Design of patient information sheets and consent forms.

o Ensure timely submission of protocol/consent documents for ethics/IRB approval. Pre study/placement and initiation visits. Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/sponsor site monitoring SOP, as appropriate

• Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets. Complete accurate study status reports.

• Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.

• Keep the Project Manager regularly informed.

• Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner.

• Ensure the satisfactory closeout 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.

• Participate in feasibility studies for new proposals as required. Ensure correct archiving of files on completion of a study.

• Maintain patient and sponsor confidentiality.

• Assume additional responsibilities as directed by the Project Manager.

• investigational Products (IPs) stored and managed by the site:

o Ensure storage conditions and acceptable supplies are provided

o Ensure IPs are supplied only to eligible patients

o Ensure IP receipt, use and return are controlled and documented

o Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.

o Act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate

• Participate in data listing reviews, as applicable.

• Responsible for cost effectiveness

• Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.

• Assist with marketing the company if and when appropriate.

• Other duties as assigned.

To be successful in the role, you will have:

• Around 2 years of independent monitoring experience in phase I-III trials as a CRA

• College degree in medicine, science, or equivalent

• Previous monitoring experience in medium-sized studies, including study start-up and close-out

• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data

• Excellent written and verbal communication

• Ability to work to tight deadlines

• Availability to travel least 60% of the time (international and domestic)

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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