Clinical Research Coordinator/RN PRN

This is a PRN position

Position Summary

Further the development of medications and therapies for people living with diabetes & related conditions through the conducting of research study visits in adherence to FDA and sponsor guidelines.

Core Job Responsibilities

This is the expected job description but the employee may be asked to perform other duties assigned by the supervisor or company leadership.

Conduct clinical studies according to GCP & FDA regulations and guidelines to ensure the safety and welfare of the study participants. Assist medical investigators in understanding and implementing the protocol. Screen potential study participants according to the protocol’s inclusion/exclusion criteria. Obtain proper written informed consent from each study participant prior to participation in the study. Plan & schedule clinical research activities. Communicate with the sponsors regarding study activities as necessary. Start IV’s, collect blood (phlebotomy), urine, and other human specimens as required by clinical studies. Obtain patient vitals and electrocardiograms ( ECG’s). Maintain patient confidentiality and follow HIPAA guidelines and regulations.

Understand the study protocol so all study activities are completed correctly and concurrently. Document the study activities with accurate and complete data. Maintain adequate and accurate case histories for each study participant. Perform internal audits of studies. Review the study protocols to capture all the supporting data to the study. Report all adverse experiences to the Investigator and sponsor. Enter the study data into the electronic case report forms in the required timelines and follow up on the queries in a timely manner. Create the source documents to ensure all data points are recorded. Complete study related training in a timely manner. Ensure protocol amendments, notices, suspensions & terminations are implemented. Maintain awareness of all regulatory documents and ensure all required documents are completed real-time to ensure we are audit ready at all time. Maintain all required documentation in the study file. Use computer applications to enhance the efficiency of the workflow and study activities. Assist with performing quality assurance measures and other quality improvement opportunities as directed by the Leadership team.

Maintain professional mannerisms in communication with the Sponsors and study personnel. Meet with sponsor representatives to discuss the conduct of the study and review study data. Inform the Sponsor of any study protocol deviations, issues with study participants, etc and proper documentation is retained. Communicate with the IRB. Maintain and enhance rapport with research partners. Communicate with sub-sites to ensure all study specific activities are covered including scheduling physicals, reviewing study procedures, etc.

Strategize with recruitment coordinators to meet the targets for each study. Actively support and contribute to patient recruitment activities including but not limited to outreach, marketing and telephone screening. Educate patients on the value of the Iowa Diabetes Portal and EMR connect.

Minimum Knowledge, Skills and Abilities Required

● RN required

● 1 to 3 years in Patient Care (Research experience preferred)

● Knowledge of business English, spelling, arithmetic, modern practices and procedures, standard office equipment

● Proficiency in Microsoft Office/Google Suite or products

● CPR certification (obtained within 6 months of start date)

Job Type: Part-time

Pay: $30.00 - $34.00 per hour

Work Location: In person