Study Start Up/Feasibility Specialist - Home-Based (US)

As a Study Start Up/Feasbility Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

This role involves coordinating and managing the start-up phase of clinical trials, including site selection, feasibility assessments, and regulatory submissions.

• Feasibility Assessments:
  • Conduct thorough feasibility assessments to evaluate the suitability of sites for clinical trials.
  • Collaborate with site investigators and study teams to gather necessary information and assess site capabilities.
• Site Selection:
  • Identify and recommend (in collaboration with CTM, and ClinOps Director(s) potential study sites based on feasibility assessments and strategic alignment with study goals.
  • Perform Investigator Due diligence check in accordance with company SOP, and/or Clinical operations processes
  • Establish and maintain relationships with site investigators and study coordinators.
• Regulatory Submissions:
  • Prepare and submit regulatory documents required for study start-up, including IRB/EC
  • submissions and regulatory agency applications.
  • Ensure compliance with all applicable regulations and guidelines.
• Start-Up Coordination:
  • In collaboration with the Sponsor Oversight managers (SOM), coordinate site initiation visits and ensure all required documentation and contracts are in place before study start.
  • Work closely with clinical operations, regulatory affairs, and other departments to ensure smooth study start-up processes.
• Documentation and Reporting:
  • Maintain accurate and up-to-date records of all study start-up activities.
  • Provide regular updates and reports to management on the status of study start-up activities.
• Compliance and Quality:
  • Ensure adherence to company SOPs, GCP, and other regulatory requirements.
  • Participate in audits and inspections as needed.

• BA/BS Degree in Business, Life Sciences, Paralegal
  • With a minimum of 3 years of independent study start-up/feasibility experience in clinical research
  • OR 10 + years of direct experience
• Strong understanding of clinical trial processes, regulations, and guidelines.
• Excellent organizational and project management skills.
• Ability to work independently and manage multiple projects simultaneously.
• Strong communication and interpersonal skills.
• Proficiency in MS Office Suite and clinical trial management systems (CTMS).

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. 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.