Sr. Clinical Trial Specialist

Sr. Clinical Trial Specialist

We are partnering with an innovative medical device company to add a Sr. Clinical Trial Specialist to support the day-to-day operations of global clinical studies. This is an excellent opportunity for someone who enjoys working in a fast-paced, collaborative environment and wants to play a key role in bringing new medical technologies to market.

• Coordinate and support clinical trial activities in compliance with GCP, GDP, FDA regulations, and company SOPs.
• Serve as a primary point of contact for clinical sites, investigators, study coordinators, and cross-functional teams.
• Manage essential study documentation, including regulatory binders, IRB submissions, informed consents, and study agreements.
• Track study progress, support patient enrollment, and maintain accurate clinical trial documentation.
• Review and resolve EDC queries while ensuring timely and accurate data collection.
• Coordinate investigator meetings, site training, and study supplies.
• Support monitoring visits and collaborate with Clinical Operations, Clinical Affairs, Safety, and other internal teams.
• Assist with adverse event documentation and overall study execution.

• Bachelor's degree in Engineering, Biology, Nursing, Life Sciences, or a related field.
• 3+ years of clinical research or medical device clinical operations experience.
• Experience with GCP, FDA regulations, and clinical trial documentation.
• Strong organizational skills with exceptional attention to detail.
• Excellent communication and relationship-building skills.
• Experience working with EDC systems and Microsoft Office.
• Ability to manage multiple priorities in a fast-paced environment.
• Up to 20% travel.