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:
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 closeout 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.
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.
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.