Hybrid Clinical Research Coordinator: Study Ops & Compliance

MNGI Digestive Health; Plymouth (MN); Hybrid; USD 60,000 - 69,000; Full time

Benefits offered by this job

Vision insurance

401(k) with company match

Profit sharing

Generous PTO

Job summary

MNGI Digestive Health is seeking a Clinical Research Coordinator to support study conduct, regulatory submissions, and training. You will work with the PI and department manager, coordinate training, and maintain study files in accordance with sponsor requirements.

Responsibilities include assisting with recruitment, informed consent, data collection, and regulatory documentation to ensure compliant study execution at our Northeast Minneapolis and Plymouth sites.

Qualifications

• Bachelor's degree in a science-related field preferred.
• Two years of Clinical Research Coordinator experience preferred.
• CCRC certification is preferred.

Responsibilities

• Coordinate with PI and Department Manager to ensure regulatory compliance and sponsor policies.
• Assist PI in developing training materials and ensure staff training documentation is complete.
• Manage and document training logs, regulatory binders, and source documents.
• Oversee recruitment activities and coordinate with Recruitment Specialist to meet enrollment goals.
• Obtain informed consent and ensure protocol adherence during participant interactions.
• Maintain study files and ensure timely data entry and query resolution.

Skills

Multitasking

Communication

Attention to detail

Problem solving

Prioritization

Teamwork

Education

Bachelor's degree in science-related field

Clinical Research Coordinator experience (2 years)

CCRC (preferred)

Tools

Microsoft Office

Electronic Health Record (EHR) system

Job description

MNGI Digestive Health is seeking a Clinical Research Coordinator to support study conduct, regulatory submissions, and training. You will work with the PI and department manager, coordinate training, and maintain study files in accordance with sponsor requirements.

Responsibilities include assisting with recruitment, informed consent, data collection, and regulatory documentation to ensure compliant study execution at our Northeast Minneapolis and Plymouth sites.