Our client, an early-stage medical device company, is redefining the battle against urological cancer through a groundbreaking advancement in therapeutic technology.

Do you have a passion for advancing medical science and improving patient outcomes? Dive into a pivotal role that's more than just a job. We’re seeking a dedicated Senior Clinical Research Associate who's ready to shape the future of healthcare!

POSITION OVERVIEW:

Join our client who is shaping transformative clinical activities. As a Senior CRA, you'll apply your clinical research expertise and deep understanding of research methodologies, regulations, and guidelines to drive our projects to success. You'll play a key role in the entire clinical trial process, collaborating closely with CROs, study investigators, and other staff. Ensure our studies remain compliant with FDA regulations, global standards, GCP, ISO, and company SOPs.

KEY RESPONSIBILITIES:

• Clinical Trial Collaboration: Work alongside our clinical team, focusing on site qualification, initiation, management, and data integrity.
• Study Documentation: Develop and review essential study materials such as case report forms, study manuals, and consent forms.
• Data Management: Oversee data activities, generate, and resolve queries, and report on study metrics including enrollment and adverse events documentation.
• Training & Compliance: Conduct site visits, train coordinators and investigators on protocol adherence, and resolve data discrepancies.
• Regulatory Oversight: Manage investigational product accountability, monitor IRB requirements, and ensure prompt processing of regulatory documents.

QUALIFICATIONS & EXPERIENCE:

ESSENTIAL:

• Bachelor’s degree in a medical/scientific field, with 4+ years of clinical research experience (Master’s degree can substitute for 1 year).
• Proficiency in FDA regulations, ICH/GCP guidelines, and MS Office tools.
• Strong organizational, multitasking, and relationship-building abilities.
• Effective communication skills and keen attention to detail.

PREFERRED:

• Experience in an FDA IDE pre-market clinical study.
• Knowledge of prostate anatomy.

WORKING CONDITIONS:

• Handle product weight up to 50 lbs. occasionally.
• Adapt to the fast-paced environment of a start-up.
• Proficiency with Microsoft Office.
• Expect travel that can be upwards of 60%.
• Hybrid role, based in Maple Grove, MN. Hybrid Schedule: Optional work from home on Monday and Friday, and in-office Tuesday, Wednesday & Thursday.