CRA I- Homebased

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies.  Monitor those sites in order 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.

Overview of the Role

• Travel (approximately 60%) domestic and/or international
• 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.
• Co-ordinate 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.
• Co-ordinate and/or participate in feasibility studies for new proposals, as require
• Investigational Products (IPs) stored and managed by the site:
• Ensure storage conditions and acceptable supplies are provided
• Ensure IPs is 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.

Role Requirements / Skills / Experience Required

• Bachelor’s degree or equivalent in medicine, science or related discipline.
• Experience should include monitoring skills and understanding of field monitoring requirements 
• Minimum of at least 1 year of clinical research monitoring experience 
• Ability to review and evaluate clinical data.
• Computer literacy desirable
• Good oral and written communication skills.