Sr. Clinical Research Associate

Sr. Clinical Research Associate

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.

As a Sr. CRA, working as a Senior Site Monitor exclusively assigned and embedded within a Pharmaceutical Company you will be responsible for successfully performing site monitoring and site management activities related to the assessment, initiation, conduct, and closure of assigned sites in Phase I-IV studies.  

The Senior Site Monitor is responsible for managing assigned sites within timelines and quality standards, and for adhering to monitoring procedures in compliance with ICH GCP, local regulations, SOPs, and study-level functional plans.

Accountabilities:                                                                                                                                                              

• As assigned to support study execution teams, responsible for the implementation of Site Monitoring and Site Management activities
  • Conducts site visits on-site and remotely to confirm initial and ongoing site suitability and to assess study conduct.  Includes pre-study, site initiation, interim monitoring, site close-out, and monitoring oversight visits.
  • Follows study-specific site monitoring plans to assess and support sites’ compliance with the protocol, data quality, and participant safety - via the review of site and subject records.  This includes but is not limited to source data verification, source data review, investigator site file review, and drug accountability activities.
  • Develops and sends confirmation and follow-up letters to provide clear communications with sites and documents all site interactions in appropriate site monitoring visit report documentation per requirements in systems.
  • Completes initial and ongoing study training; delivers and documents relevant study training with site personnel.
  • Reviews systems and dashboards to prepare for site interactions and to assess site compliance with study requirements (e.g., EDC status as well as eCOA compliance).   Partners with RBQM Operations to address centralized monitoring findings with sites, and support sites in RBQM processes.
  • Provides ongoing site support / management, liaising with sites to address questions, triage study needs, and resolve issues with and for sites.   Escalates site issues as needed to Clinical Operations representatives (e.g., CSSM, CSM, RBM Lead).
  • Conducts Monitoring Oversight Visits to assess site monitoring quality and/or resolve issues in site data quality or site monitoring quality for additional sites/studies as requested.
• Maintains high quality, consistency, and compliance with procedures across studies
• Recommends monitoring process adjustments based on experience during and after the completion of study activities
• Acts as a change agent, subject matter expert, and point of contact for risk-proportionate site monitoring concepts with study teams
• Supports and participates in internal and external audits and inspections as requested

Education & Competencies (Technical and Behavioral):

Education: Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience

Experience:

• Minimum of 5 years of experience in Site Monitoring / Site Monitoring Management, or Risk Based Monitoring roles with Sponsors or CROs
• Robust understanding of the drug development and clinical trial execution processes
• Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6 (GCP)

Skills:

• Experience successfully delivering site monitoring and risk-based monitoring, including onsite and remote monitoring models
• Experience in navigating external vendor portals / reports, and knowledge of Veeva EDC, TMF, and CTMS

Behavioral Competencies:

• Pragmatic and comfortable with evolving processes; willing to drive and support change
• Excellent teamwork, organizational, interpersonal, and problem-solving skills
• Clear communication style with a demonstrated ability to think critically, collaborate, and influence without authority
• Ability to embrace and demonstrate a growth mindset focused on diversity and inclusion

Travel Requirements:

• Requires minimum 50% travel, including overnight and potentially international travel

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