CRA II

As a (CRA I, II) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Within this program you will thrive within a fast-paced, dynamic study design. As we are fully embedded with this global pharmaceutical client, you will experience a true “one team” approach that provides limitless opportunity to develop through training, mentorship, and support from leadership.

What you will be doing:

• Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
• Acts as primary local company contact for assigned sites for specific trials.
• Attends/participates in investigator meetings as needed.
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
• Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
• Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
• Arranges the appropriate destruction of clinical supplies
• Ensures site staff completes the data entry and resolve queries within expected timelines.
• Ensures accuracy, validity and completeness of data collected at trial sites
• Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents.
• Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints.
• Fully documents trial related activities in particular monitoring. Writes visit reports and uploads into eTMF for review and approval.
• Complete follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team.
• Promptly communicates relevant status information and issues to appropriate stakeholders.
• Follows the corresponding Monitoring Guidelines for each assigned trial.
• Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times.

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You are:

• Experience should include monitoring skills. Prior relevant active independent field monitoring experience and site management experience
• Strong knowledge in ICH-GCP
• Ability to review and evaluate clinical data
• Computer literacy desirable
• Professional use of the English language; both written and oral
• Good oral and written communication skills
• Due to the nature of this position it may be required for the employee to travel
• Home-Based
• At least+1.5 years SIT On-Site Monitoring Experience with global oncology studies as CRA

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.