Senior Cra / Cra Ii
Senior CRA - ICON Biotech ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Senior Clinical Research Associate to join our diverse and dynamic Biotech team. Our biotech division of 8, 000+ people operates with a mindset aligned to small and mid-sized biopharma. Our tailored teams and management understand the different pressures that are faced by biotechs and will engage, collaborate and share ownership in the delivery of the clinical trials.
As a Senior Clinical Research Associate you'll work alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for these clinical studies 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.
What You Will Be Doing: Working independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation. Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested. Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required. Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness. Dependent on level of experience you may assist in training and mentoring less expert CRAs and/or lead CRAs working on international projects. Your Profile: A minimum of 2. 5 years independent monitoring experience in phase I-III trials as a CRA. Knowledge of ICH-GCP guidelines and expertise to review and evaluate medical data. You will possess excellent written and verbal communication in English and Italian. Ability to produce accurate work to tight deadlines within a pressurized environment. You will be asked to travel (domestic - fly and drive) and should possess a valid driving license. 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 maximize 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 specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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 or submit a request here.
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.
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