Clinical Study Team Associate

Clinical Study Team Assistant (CSTA)

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 Clinical Study Team Assistant (CSTA) is an essential part of the Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and SOPs. The role collaborates with global study team members and is responsible for multiple tasks that span from study start-up to study close-out which enables the efficient execution of clinical trials to high quality standards. 

What You Will Do:

You will lead on clinical coordination tasks requiring technical depth, with a focus on quality and continuous improvement.

Key responsibilities include:

• Management and oversight of Study Team shared spaces

• Trial Master File (TMF) maintenance, compliance, and oversight

  • Analyze, interpret, and follow up on metrics

• Management and oversight of Study Team on Demand (STOD)

  • Analyze, interpret, and follow up on metrics

• Maintain Pfizer registries and systems as required to ensure compliance

• Tracking and oversight of study information; follow up with functional lines as needed

• Liaising with cross functional study team members:

  • Initiate and coordinate the completion of study level forms and data entry into various clinical operations applications and systems

  • Provide study level reporting to support management of clinical trial data, clinical trial budget and timelines 

• Quality control of essential clinical trial documentation including components of the Clinical Study Report (CSR) and regulatory submission

• Support engagement of Independent Oversight Committees

• Provide support with audit and inspection readiness activities

• Assist with oversight and tracking of Clinical Trial Budget spend

• Provide logistical and operational support for Investigator Meetings

• Coordinate the translation of documents as required

• Provide status updates on key tasks and contribute to the Study Team Meetings as an active Study Team member 

• Provide support to study teams with system setup and maintenance

• May provide support for global study team communications to sites

Your Profile:

You will have a strong foundation in clinical coordination, with the experience to work independently and guide others.

Required qualifications and experience:

• 1-3 years exp with BA/BS or 1+ years exp with MA/MBA/MS

• Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)

• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research

• Science background

• Experienced with clinical trial processes and applicable systems

• Effective verbal and written communication skills

• Ability to work independently but also as part of a larger team with limited support from supervisor

• Ability to multitask and manage multiple competing priorities

• Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality

• Knowledge of drug development process

• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.

• Good problem solving & decision-making skills: Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problems

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