Senior Clinical Research Associate - Central - Cardio Medical Device - Lifelancer

As a Sr CRA you will be joining the world’s largest most comprehensive clinical research organisation, powered by healthcare intelligence.

What will you be doing?

• To support cardiovascular/electrophysiology medical device space
• 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 SM-training 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
• 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 You Need To Have

• • A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
  • Associates Degree with 5+ years of monitoring experience will be considered. 4-year degree preferred
  • The ideal candidate will be located in the Central region of the country and flexible to co-monitor/provide coverage across the US.
  • To support in the cardiovascular/electrophysiology medical device space.
  • Electrophysiology/cardiac medical device monitoring experience preferred, however, strong cardiology pharma monitoring experience or any background in electrophysiology will be considered in lieu of medical device monitoring experience
  • Candidates must have a well-executed plan for communication with the study teams and sites.
  • Candidates must show collaboration and willingness to work within a team environment.
  • Analytical/risk-based 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 self-starter with the ability to work independently.
  • Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
  • Ability to travel up to 65%
  • 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.
    

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: 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. Were 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.