As a Sr CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
ResponsibilitiesWhat will you be doing?
Works on multiple trials within Oncology Quality of life focus wtih Regional TravelDemonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes • Mentors/coaches junior flex teamActs as Lead SM-training other SMs on studyDevelops site start up documents for studies including SIV agendaProvides 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 trialSupports country budget development and/or contract negotiation in liaison with CCS colleaguesAssists with ASVMetrics/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.) QualificationsQualifications Needed:
Based in the Los Angeles, CA area (near a major airport) Have a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological SciencesHave a minimum of 3 years’ experience in monitoring pharmaceutical industry clinical trialsHave a minimum of 1-3 years' experience monitoring Oncology trialsKnowledge of several therapeutic areas, with oncology an asset but not a requirement.Analytical/risk-based monitoring experience is an assetAbility to actively drive patient recruitment strategies at assigned sitesAbility to partner closely with investigator and site staff to meet all of our study timelinesAbility 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 self-starter with the ability to work independently.Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.Need to travel up to 50%
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:
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.