ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies ICON enjoys a strong reputation for quality and is focused on staff development.
Post : Clinical Research Associate II
Position Summary
• 4+ years of experience in monitoring
• hands-on experience in Oncology Trials & Therapeutic area
• Required days on-site - 8.5 to 12 Days per month.
• PAN India Travel involved.
Job Description :
• Recognize, exemplify and adhere to ICON"s values which center around 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 :
• Identify investigators.
• Help when requested , in preparation of regulatory submissions . Design of patient information sheets and consent forms .
• 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 close-out 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
lnvestigational Products (IPs) stored and managed by the site:
• Ensure storage conditions and acceptable supplies are provided
• Ensure IPs are supplied only to eligible patients
• Ensure IP receipt, use and return are controlled and documented
• Ensure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.
• 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.
Technical and competency selection:
When you spot an opportunity you're interested in and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business. The evaluation will look at your technical skills and your competencies - for example, delivering excellence.
Interview
After this, we'll let you know if we'll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.
Additional Information
Experience : 4+ years
Location : Bengaluru
Industry Type : Pharma / Healthcare/ Clinical research
Reference : JR061938
End Date : 30th January, 2020
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