What you will be doing:
The Clinical Research Associate (CRA) - will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Therapeutic area is Medical Device - Connected Care Group - Patient Management Monitoring
- Provide leadership in execution of clinical studies to deliver high quality data to support sponsor on time, within budget and in compliance to all applicable regulations and procedures
- Drive adoption of compliant clinical study execution practices throughout sponsor active in clinical studies including research and testing of products involving human beings
- Develop and maintain the policies and procedures for the Clinical Operations function of Clinical and Medical Affairs.
- Support, update and maintain the Clinical Trial Management System application for clinical study execution and reporting.
- Ensure the clinical studies are conducted according to procedures including up to date and complete trial master files, regular review of data, and assurance that monitoring reports are completed within two weeks of visit date.
- Ensure that monitoring plans are created and followed with monitoring documentation to support this included in the applicable Trial Master Files.
- Act as Clinical Study Manager for designated clinical studies under the guidance of your Manager and may support other studies in this role as applicable.
- Attend all required meetings and provide updates to team.
- Support EDC user acceptance testing and training as applicable
- Oversee and support the creation of the trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation
- The Clinical Operations Senior Clinical Research Associate (CRA) is responsible for monitoring and leading the monitoring of clinical research studies involving human subjects from its inception to close-out according to budget and timelines.
- Qualifies, Selects, Trains and Monitors internal and external study Investigators and study documentation.
- May be the lead for site management and expected to communicate well with internal and external business partners including key opinion leaders.
- Works on issues where analysis of situation or data requires review of relevant factors.
- Typically acts as a lead, coordinating the work of Specialist or Coordinator, but is not a supervisor
You are:
- 3 plus years of clinical monitoring
- Knowledge of ICH and local regulatory authority regulations regarding drug
- Device experience required
- Experience in using EDC and CTMS systems is desirable
- Knowledge of Sharepoint and Excel is helpful in this role
- Experience with direct line management of staff including hiring, training, oversight and mentoring
- Good command of written and spoken English language
- Excellent verbal and written communications skills
- Excellent interpersonal and organizational skills
- A pro-active, committed and motivated attitude
- A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations
- Ability to work very accurate and thorough
- Excellent record-keeping skills; good documentation practice
- Ability to maintain excellent working relationships with a broad range of clinical study staff.
- Ability to work well in a team environment but also independently without significant oversight
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
- Flexibility in work hours and readiness to travel.
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:
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.
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.