Senior Clinical Research Associate Home based France
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
For our client, a growing BioTech with an interesting pipeline, we are looking for an experienced Clinical Research Associate. Our client is a Global Biotech company with Headquarters in the United States. They are focussed on exploring new dimensions in biology by transcending disciplines.
For the (Senior) Clinical Research Associate role, we are looking for Experienced Clinical Research Associates, willing to work within the field of oncology. Therefore, we are looking for candidates with an extended oncology experience.
What You Will Be Doing:
* Perform site qualification, site initiation, and closeout visits, ensuring regulatory and protocol compliance. Visits may be on-site or remote.
* Generate queries and manage resolutions with site personnel.
* Document activities via confirmation letters, follow-up letters, trip reports, communication logs and other required study documents as per SOPs and Study Monitoring Plan.
* Perform investigational product accountability as per the protocol and Study Monitoring Plan.
* Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected.
* Act as primary liaison with site personnel.
* Management and collection of site's study regulatory documents.
* Enter data into tracking systems as required.
* Assist and support audit preparation and CAPA implementation.
* AE/SAE and expedited reporting and management.
Required Skills
* Degree in life sciences, pharmacy preferred.
* Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
* Proven experience in on-site monitoring of clinical studies is a must
* Oncology experience
* Leadership skills, engaged to grow within the organisation
* Site Engagement: building excellent site relationship skills
* being able to map risks and challenges, and proactively work to mitigate.
* Excellent communication skills in English, French, Dutch
#LI-VV1
#LI-Remote
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 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 site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. 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 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.
Are you a current ICON Employee? Please click here to apply