Research Coordinator II - Study Operations & Compliance

The Chronicle Of Higher Education, Inc.; Salt Lake City (UT); On-site; USD 47,000 - 60,000; Full time

Job summary

The Chronicle of Higher Education, Inc. seeks a Research Coordinator (Non-R.N.), II to oversee day-to-day research activities, ensure adherence to RCR and study protocols, and support initiation and close-out of studies.

You will develop tools, maintain source documents, and coordinate site visits and stakeholder communications. Responsibilities include protocol review, regulatory submissions, coordinating participant visits, informed consent, data entry, and liaison with PI and departments to

Qualifications

• 1 year of higher education can be substituted for 1 year of directly related work experience.
• Requires bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience.
• Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; ability to function independently is preferred.

Responsibilities

• Reviews assigned research protocols in detail, including objectives, design, criteria, visits and other details.
• Prepares, submits, and maintains regulatory documents and research correspondence (IRB, FDA, NCI, NIH, NSF).
• Coordinates participant study visits and related facility, drug/device, and equipment availability.
• Obtains informed consent and addresses participants' concerns with the PI.
• Completes, audits, and revises case report forms and enters data into electronic data capture systems.
• Accesses Electronic Medical Records to obtain medical history, labs, and other data.
• Maintains source documents and subject logs to ensure subject safety.

Education

Bachelor's degree or equiv.

Master's degree or equiv.

Job description

The Chronicle of Higher Education, Inc. seeks a Research Coordinator (Non-R.N.), II to oversee day-to-day research activities, ensure adherence to RCR and study protocols, and support initiation and close-out of studies.

You will develop tools, maintain source documents, and coordinate site visits and stakeholder communications. Responsibilities include protocol review, regulatory submissions, coordinating participant visits, informed consent, data entry, and liaison with PI and departments to