Job Title: Senior Clinical Research Associate Oncology West
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation powered by healthcare intelligence.
What will you be doing
Works on multiple trials within Oncology
Quality of life focus wtih Regional Travel
Demonstrated leadership through involvement in specific initiatives when needed and/or SME to systems and/or processes
Mentors/coaches junior flex team
Acts as Lead SMtraining other SMs on study
Develops site start up documents for studies including SIV agenda
Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines)
Represents LTMs or SMs on SMTs/meetings
Takes over LTM role reports review (SQV SMV SCV) for sites assigned to other SMs from the same trial
Supports country budget development and/or contract negotiation in liaison with CCS colleagues
Assists with ASV
Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces – Primary/Other
Primary interfaces: Provider Functional Manager Clinical Trial Assistant Local Trial Manager and Central Study Team for assigned clinical trials.
Other Interfaces: Study Responsible Physician Regional Quality and Compliance. Manager/Specialist Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators pharmacists etc.
What do you need to have
Have a minimum of a B.S. R.N. or equivalent degree preferably in Biological Sciences
Must be located in the West region near a major airport
Have a minimum of 3 years’ experience in monitoring pharmaceutical industry clinical trials
Have atleast 1 year preferably 2 plus years experience monitoring Oncology trials (CART experience highly preferred)
Knowledge of several therapeutic areas
Analytical/riskbased monitoring experience is an asset
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet all of our study timelines
Ability to operate and use various systems and databases (e.g. CTMS EDC eTMF various dashboards/metrics IWRS safety reporting).
Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and selfstarter with the ability to work independently.
Have an indepth knowledge of Good Clinical Practice ICH guidelines and local regulatory requirements.
Need to travel up to 50
To qualify applicants must be legally authorized to work in the United States and should not require now or in the future sponsorship for employment visa status.
Pay Range $91336.00 USD – $114170.00USD)
Actual compensation will be determined based on factors such as geographic location work experience education/training and skill level.
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 wellbeing 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 24hour access to a global network of over 80000 independent specialised professionals who are there to support you and your family’s wellbeing
Life assurance
Flexible countryspecific 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/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/reasonableaccommodations
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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