Clinical Trial Specialist - U.S.

Position Summary

The Clinical Trial Specialist (CTS) is a member of the Clinical Operations team and is responsible for providing operational support for the day-to-day management of one or more global clinical trials in cooperation with the Clinical Operations team leaders. This position reports to the Senior Director, Clinical Project Management.

Key Responsibilities

• Ensures timely and accurate study document creation in cooperation with the Clinical Project Lead and Site Relationship Manager, including but not limited to study manuals, newsletters, presentations, study-specific plans, case report forms and support materials
• Aids in reviews of country and site-specific Informed Consent Forms and site budgets
• Coordinates/schedules meetings with external and internal project teams and vendors. Distributes agendas, takes/distributes meeting minutes and provides follow up correspondence as needed
• Reviews essential documents required for IRB/EC submission and IMP delivery and follows up with CRO if missing or corrected documents are required
• Creates and maintains study trackers, such as but not limited to documents version tracker, lab shipments, equipment requests, enrollment, team rosters, site contracts and budgets, team training
• Additional duties as designated by the Clinical Project Lead

Qualifications

• B.A. or B.S. degree, preferably in a scientific discipline
• A minimum of 3 years of industry experience in a pharmaceutical /biotech or CRO as a CTS or Clinical Trial Assistant or Clinical Site Study Coordinator experience
• Solid understanding of ICH guidelines and regulatory requirements for clinical trials
• Strong organizational skills, and attention to detail
• Proficiency with computer software including MS Office applications and SmartSheet
• Excellent written and verbal communication skills
• Comfortable working in a demanding, fast-paced, start-up culture with evolving processes

Benefits

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.