Senior Clinical Research Associate - Malaysia - Homebased
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.
The Role:
Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites 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:
Recognize, exemplify, and adhere to ICON's values which center around our commitment to People, Clients, and Performance.
Embrace and contribute to our culture of process improvement with a focus on streamlining processes and 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 Clinical Research SOPs/WPs, ICH, GCP, and appropriate regulations.
Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
Recruitment of investigators.
Independent and proactive coordination of all necessary activities required to set up and monitor a study, including:
Identify investigators.
Assist in the preparation of regulatory submissions.
Design patient information sheets and consent forms.
Coordinate documents translation, verification, and back translations where required.
Ensure timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements.
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 to achieve recruitment targets.
Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.
Keep the project manager or designees regularly informed.
Process case record forms to the required quality standards and timelines.
Ensure the satisfactory close-out of investigator sites.
Participate in the preparation and review of study documentation, e.g., draft protocols, draft CRFs, monitoring guidelines, and elements of the final report.
Ensure correct archiving of files on completion of a study.
Maintain patient and sponsor confidentiality.
Assume additional responsibilities as directed by Project Manager (PM).
Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.
To be successful in the role, you will have:
18 months+ of monitoring experience in phase I-III trials as a CRA.
Knowledge of ICH 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.
Valid driving license and ability to travel at 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.#J-18808-Ljbffr