Fortrea is a leading global Contract Research Organization (CRO) that combines scientific rigor with decades of clinical development expertise. We deliver comprehensive solutions for pharmaceutical, biotechnology, and medical device clients, helping to advance clinical development, patient access, and technology solutions across over 20 therapeutic areas. Operating in more than 90 countries, Fortrea is committed to transforming the way drugs and devices are developed, ensuring the swift delivery of life-changing therapies to patients worldwide.
As a Clinical Study Support Specialist, you will assist with the overall operations associated with the setup, planning, and maintenance of clinical studies. Your role will include supporting the team and providing excellent service to Sponsor-Investigators. You will also play a key part in ensuring quality and efficiency in all study-related activities, acting as a support function for project groups and internal teams.
Clinical Study Set-Up & Maintenance:
Manage the setup, planning, and ongoing maintenance of clinical studies within the client portal. Ensure accurate and timely updates for study protocols, regulatory changes, and data inputs.
Client & Investigator Coordination:
Regularly follow up with customer points of contact (POCs) for updates on protocol/study design. Track progress and ensure all milestones are met according to the agreed-upon timelines. Coordinate safety information transfer and any study amendments with Investigator sites.
Reporting & Metrics:
Assist in generating monthly status reports and project-specific updates, ensuring the quality and accuracy of metrics and data provided. Provide forecasting updates to clients based on the investigator’s enrollment plan.
Training & Mentorship:
Support and mentor less experienced safety staff in all aspects of clinical study operations. Train staff on internal processes, SOPs, and client-specific protocols.
Compliance & Documentation:
Ensure compliance with eTMF filing plans and support investigator site staff with guidance via raised queries in the client communication portal. Prepare study files for archiving upon project completion.
Risk & Milestone Monitoring:
Monitor milestones, identify potential risks to study timelines, and escalate any concerns to the client in a timely manner.
Governance Support:
Prepare and support presentations for customer governance calls, ensuring effective communication with stakeholders regarding study progress.
Education & Experience:
A background in life sciences or a related field is preferred. Experience in clinical operations, study management, or a related area is beneficial.
Skills & Competencies:
Additional Requirements:
Fortrea is dedicated to overcoming barriers in clinical trials and bringing life-changing therapies to patients around the world. Join our innovative and supportive team where personal growth is nurtured, and where you can make a global impact through collaboration and creativity.
Fortrea is an Equal Opportunity Employer (EOE) and encourages applicants from diverse backgrounds to apply. We do not tolerate harassment or discrimination of any kind and are committed to fostering an inclusive and respectful workplace.
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Goa | Panaji |Gujarat :
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Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |North Carolina :
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Rostock |Munich :
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Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Denmark :
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Seoul |Capital of Netherland :
Amsterdam |Remote :
Switzerland | Remote, USA | Remote - Europe | Remote |Makkah :
Najran | Rabigh | Riyadh | Khulais | Jeddah |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |