Sr. Clinical Trial Specialist
custom searchMaple Grove, MN
Sr. Clinical Trial Specialist
custom searchMaple Grove, MN
2 days ago
Industries
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)Research and Development in Biotechnology (except Nanobiotechnology)Electromedical and Electrotherapeutic Apparatus ManufacturingAbout the role
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.
Your Role With The Company:
- 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.
- Desired Profile:
- 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.
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JOB OVERVIEW
Experience level
Senior
Location
Maple Grove, MN
Occupation
Clinical Research Coordinators
Industry
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Posted
2 days ago
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