Job Description
Study Start-Up CRA - California
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
The Study Start Up CRA is accountable for site selections as well as study specific start up activities and deliverables of assigned sites for Phase I-IV trials in the country in accordance with monitoring procedures and processes following ICH.GCP, local regulations and SOPs
Proactive site preparation and early identification of real site needs and issues and close handover execution CRA for all sites in key (from issue management to risk identification).
What you will be doing: - Supports country SSU strategy in close collaboration with the SSO Study Start Up Team Lead, the SSO Study Start Up Manager and the SSO Feasibility Manager as well as the SSO Site Partnership Manager
- Collaborates with the SSO Study Start Up Manager, the SSO Study Start Up Team Lead and global study team to ensure Study Start Up timelines and deliverables are met according to country commitments
- Accountable for timely start up activities from country allocation until site greenlight at assigned sites
- Conducts site selection visits, verifies site eligibility for a specific study
- Acts as the main contact for trial sites during site selection, study start up and IRB/IEC and HA submission preparation
- Ensures that milestones (KPIs) and time schedule for study start up are met as planned
- Facilitates the preparation and collection of site and country level documents
- Collects submission-related site-specific documents for all relevant site personnel within agreed timelines (e.g. FD, CV, GCP certificates, DSL, etc.)
- Support the SSU Manager with preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
- Supports the SSO Study Start Up manager and assigned sites with vendor set-up activities
- Prepares and finalizes site specific documents for submission
- Negotiates investigator payments, as needed
- Supports, preparation of financial contracts between sponsor and investigational site sand investigators, as needed
- Updates all systems until site Green Light on an ongoing basis
- Supports preparation of audits and inspections, as applicable
- Supports reduction of formal site specific IRB/IEC deficiencies
- Ensures timelines, accuracy, and quality of country and site TMF documents in study start up to ensure TMF inspection readiness
- Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
- Implements innovative and efficient processes which are aligned with the sponsor strategy
- Ensures sites are prepared for “Green Light” and is accountable to send the Green Light to the SSU Manager for review and approval
Your profile: - A holder of a Bachelor's degree in a scientific or healthcare-related field (highly preferred).
- An experienced Clinical Research Associate with a minimum of 2 years of on-site monitoring experience.
- Knowledgeable in clinical trial processes, regulatory requirements, and ICH-GCP guidelines.
- Detail-oriented with strong organizational and communication skills.
- Able to thrive both independently and as part of a collaborative team in a fast-paced environment.
- Experienced with 2-3 years in Site Start-Up (SSU) activities.
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 maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here
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.
Are you a current ICON Employee? Please click here to apply
Job Tags
Remote job, Permanent employment, Local area, Flexible hours,