What You'll Do
Oversee key aspects of a clinical study, including participant enrollment, long-term follow-up activities, and maintenance of the trial master file. Support the timely activation of study sites and ensure ongoing compliance with regulatory standards through regular audits of study documentation.
Monitor device accountability and perform reconciliation to maintain accurate records throughout the trial. Analyze protocol deviation data to support trending and reporting requirements. Generate weekly status updates and document meeting minutes to keep stakeholders informed.
Collaborate on the planning and coordination of investigator meetings, contributing to the development of necessary materials. Maintain clear and consistent communication with leadership regarding study progress, challenges, and upcoming milestones.
Requirements
- Hold a Bachelor’s degree in a scientific discipline
- Demonstrate understanding of Good Clinical Practice (GCP) and regulatory guidelines for clinical trials
- Have at least three years of direct experience in clinical research or a related medical/scientific field
- Possess strong written, verbal, and interpersonal communication abilities, with fluency in medical terminology
- Show proficiency with MS Office, word processing, and spreadsheet applications
- Exhibit meticulous attention to detail, organizational capability, and the ability to manage multiple priorities
- Work effectively within cross-functional teams and maintain a professional demeanor
- Demonstrate problem-solving aptitude, dependability, and adaptability in a fast-paced environment
Preferred Qualifications
- A Master’s degree may be accepted in place of one year of required experience
- A PhD or MD may substitute for two years of experience
- Prior experience in clinical trial execution, site management, or medical device studies is advantageous
Work Mode
This role is based onsite in Mounds View, MN. Candidates must be able to work from this location for the duration of the contract, which spans at least six months with potential for extension.
