Clinical Trial Assitant
About the role
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Hi,
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.
We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.
Job Title : Clinical Trial Assistant
Type of Employment : Full Time
Location : ICON PLC, INDIA
Responsibilities:
Job Description
· Recognize, exemplify and adhere to ICON's values which center around excellence in execution, exceeding expectations, and enhancing relationships
· 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
· Travel (approximately 10%) domestic and/or international
· To possess a knowledge of ICH GCP, appropriate regulations, relevant ICON SOPs, ICON internal tracking systems, and Client SOPs / Client systems (when applicable)
· To assist the project teams with the set-up, organization and maintenance of clinical study documentation (e.g. Study Files, CRFs, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival
· To assist in the processing of Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study
· To share responsibility in the quality control audits of clinical study documentation (e.g. Study Files, CRF Files, Monitoring Files, etc.) to ensure study files are inspection ready at all times
· To facilitate and coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies, and study binders) as appropriate
· To assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as appropriate)
· To run, review and analyze study reports for accuracy and work with the project teams to ensure updates are completed correctly
· To assist in coordination of study related payments, if applicable
· To contact and serve as a contact for clinical sites for basic requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)
· To assist in the tracking and distribution of safety reports
· To coordinate document translation, if required
· To assist and attend the Project team with meeting coordination, activities preparation, generation of meeting minutes and agendas
· To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations
· To assist with the coordination of various tracking reports, including but not limited to, team member tracking and training
· To work in collaboration with internal and external colleagues to meet project objectives and timelines
· To Keep the Project Manager / Project Director / Clinical Operations Designee informed of any issues within the Project Team which require attention
· To maintain client and patient confidentiality
· Other duties as assigned
Benefits of Working in ICON
In comparison with our competitor’s and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer’s to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market.
We are more like an extended family with consideration of staff as individuals allowing a work-life balance.
You would be joining us at the very right time – just when we won the Best Contract Research Organisation Award at the annual Scrip Awards 2017.
If you would like more information please visit our company website: http://www.iconplc.com/ or careers.iconplc.com.
PROCESS
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.
Offer
If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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