Clinical Trial Associate, Medical Device, Global IDE Study
BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION
Our client is a PE-backed, Massachusetts-based medical device company advancing next-generation technologies in atrial fibrillation and cardiac ablation. With two global Class III IDE studies launching, the Clinical Operations team is expanding to support the volume, speed, and complexity of upcoming trials.
The CTA will serve as an essential in-house resource supporting multiple Project Managers and clinical studies. This role will provide hands-on operational support, helping maintain documentation, study materials, and core processes required for successful global IDE execution. This is an excellent opportunity for an early-career clinical professional looking to gain broad exposure in a fast-paced, high-growth environment.
DUTIES / EXPECTATIONS OF THIS ROLE
• Prepare, assemble, and maintain investigator/site binders and study materials
• Assist with regulatory document collection, routing, and tracking
• Maintain clinical tracking logs, TMF documentation, and enrollment records
• Support Clinical Project Managers with meeting prep, minutes, follow-ups, and correspondence
• Coordinate shipping, printing, and organization of essential study documents
• Upload and manage files within clinical systems (TMF, eTMF, CTMS, etc.)
• Assist in maintaining inspection-ready documentation across all studies
• Serve as an internal point of contact for clinical teams, field staff, and site personnel
• Support day-to-day administrative and operational tasks across multiple studies
MUST HAVES - QUALIFICATION SUMMARY
• Bachelor’s degree in biology, Life Sciences, or related field
• 0–2 years of experience in Clinical Research, Clinical Operations, or related area
• Strong organizational skills with exceptional attention to detail
• Comfortable working in a fast-paced environment supporting multiple stakeholders
• Strong communication and time-management skills
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
NICE TO HAVE
• Prior CTA, Research Assistant, or Clinical Research internship experience
• Familiarity with GCP, ICH guidelines, and basic clinical trial documentation
• Experience supporting Class II or III medical device studies
• Experience with TMF/eTMF or CTMS systems
TRAVEL & LOCATION
On site, Marlborough, MA
START & TERM
January 2026 Start Date
Full time 40-hour work week available – Permanent or Contract-to-hire
W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
Eliassen Group is an Equal Opportunity/Affirmative Action Employer .
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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