What are the responsibilities and job description for the cra position at ICON Strategic Solutions?
Job Title: Clinical Trial Assistant
Join a world-leading healthcare intelligence and clinical research organization as a Clinical Trial Assistant.
The ideal candidate will be part of our clinical trial team, supporting the delivery of clinical studies within the sponsor. Key responsibilities include ensuring operational deliveries are executed on time, within budget, and at high quality from protocol development through study setup, maintenance, close out, and study archiving.
Main Responsibilities:
- Support the study team in delegated activities to ensure efficient execution of clinical trials in line with ICH/GCP sponsor SOPs and regulatory regulations.
- Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS).
- Create and maintain communication platforms, including support for clinical trial registration and disclosure on websites per applicable regulatory requirements.
- Guide study team members on eTMF/paper TMF document transfer and archival, lead quality check (QC) per the TMF plan, and help draft TMF plans.
- Facilitate finance-related activities such as sign off, IO, and PO setup, processing invoices, tracking accruals, and budgeting for maintenance and reconciliation for sites and third-party vendors.
- Support oversight of monitoring visit report review, data oversight, and reconciliation efforts, vendor systems, SAEs, protocol deviations, and more as needed per study.
- Compile and maintain clinical trial-related lists and logs, including study document version tracker, decision risk log, contact list, Q&A log, vendor list, and specific training log.
- Draft and distribute newsletters and communications materials to internal and external stakeholders.
- Complete delegated tasks during audit and inspection by regulatory authorities.
Requirements:
- Bachelor's degree or above (Life Sciences preferred) or certification in a related health profession (e.g., nursing, medical, or laboratory technology) from an accredited institution.
- At least 1 year of experience as a CTA, CRC, or other role in clinical trials.
- Computer proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
- Position is on site 3 days a week at the South San Francisco, CA office and 2 days from home.
About Us:
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.
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.
Benefits:
A range of health insurance offerings to suit you and your family's needs, competitive retirement planning offerings, global Employee Assistance Program, TELUS Health, 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.
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers website to read more about the benefits of working at ICON.
