CRA I

As a Clinical Research Associate I at ICON, you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - III, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

• At least 12 months experience as an independent monitor
• 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.
• Travel (approximately 60%) domestic and/or international.
• Familiarity with ICON's SOPs/WPs, ICH-GCP and appropriate regulations
• Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.
• Familiarity with principles of investigator recruitment.
• Assist with coordinating all the necessary activities required to set up and monitor a study, including the following identifying 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/WP 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.
• Ensure correct archiving of files on completion of a study.
• Co-operate with sponsor and/or ICON QA personnel in the conduct of QA audits.
• Participate in feasibility studies for new proposals, as required
• Maintain patient and sponsor confidentiality .
• 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.
• To 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 data listing reviews, as applicable.
• Assist with marketing the company if and when appropriate.