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ICON hiring for Clinical Research Associates in (Gurgaon, Delhi and Mumbai) Apply Now
About the job
We are hiring for Clinical Research Associates in (Gurgaon, Delhi and Mumbai):
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.
Job Profile Summary
- Identify, select, initiate and closeout appropriate investigational sites for clinical studies.
- Monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with ICON SOPs/WPs applicable regulations and the principles of ICH-GCP.
- Provide a benchmark of monitoring competence to inexperienced/less-experienced colleagues.
Job Description:
• 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.
For more details kindly reach out to Gayathri.Nareshkumar@iconplc.com
