Senior Clinical Research Associate - All US locations
About the role
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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 I 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 Clinical Research SOPs/WPs, ICH, GCP and appropriate regulations
- Expert knowledgeable of ICON systems
- Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
- Recruitment of investigators.
- Independent and proactive co-ordination of all the necessary activities required to set up and monitor a study, including the following:
- Identify investigators.
- Help, when requested, in 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
- 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 or designees 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.
- Ensure correct archiving of files on completion of a study.
- Maintain patient and sponsor confidentiality.
- Assume additional responsibilities as directed by Project Manager (PM)
- Responsible for the conduct/management of any aspect(s) of a project, when requested and authorized by a Project Manager.
- Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.
- Coordinate and/or participate in feasibility studies for new proposals, as required.
- Investigational 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.
- Be cost effective.
- Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
- Participate in data listing reviews, as applicable.
- Assist with marketing the company if and when appropriate.
- Other duties as assigned.
Skills, Experience, and Education
- Experience should include monitoring skills. Experience should be a minimum of 3 years of active independent field monitoring and site management experience.
- Ability to review and evaluate clinical data arising from aptitude and have the required level of experience in clinical research.
- Must be able to travel 65%-75% per month
- Bachelors degree, or local equivalent, in medicine, science, or related discipline is required.
Application process
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Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
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