Clinical Research Coordinator — Regulatory & Trial Coordination

Mngastro; Minneapolis (MN); On-site; USD 60,153 - 69,180; Full time

Benefits offered by this job

401K with company match

Profit sharing

Generous PTO

Holiday Pay

Floating Holiday

Short & Long-Term Disability

Paid Leave and Disability

Discretionary Bonus

Job summary

MNGI Digestive Health is seeking a Clinical Research Coordinator to support protocol execution, training, and documentation for clinical studies. The role requires ensuring regulatory compliance and coordinating with the PI, staff, and sponsor teams.

Responsibilities include protocol oversight, data collection, recruitment support, and preparation of regulatory submissions, with emphasis on accurate record-keeping and good communication across departments.

Qualifications

• Bachelor's degree in a science-related field; preferred.
• Two years' experience as a Clinical Research Coordinator.
• Experience with an electronic health record is preferred.

Responsibilities

• Coordinate clinical research activities in accordance with federal regulations and GCP.
• Develop training materials and ensure staff completion.
• Assist in recruitment and informed consent processes.
• Manage study documentation and regulatory binders.
• Oversee investigational product handling and data collection.
• Prepare IRB submissions and regulatory reports.
• Maintain communication with sponsor, CRO, and PI.

Skills

Microsoft Office

Medical terminology

Problem solving

Attention to detail

Multitasking

Communication skills

Teamwork

Typing

Independent work

Education

Bachelors degree in science

CCRC certification

Job description

MNGI Digestive Health is seeking a Clinical Research Coordinator to support protocol execution, training, and documentation for clinical studies. The role requires ensuring regulatory compliance and coordinating with the PI, staff, and sponsor teams.

Responsibilities include protocol oversight, data collection, recruitment support, and preparation of regulatory submissions, with emphasis on accurate record-keeping and good communication across departments.