CRA I

Clinical Research Associate I

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

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.

• Why join us?

• Ongoing development is vital to us, and as a CRA II you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

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