Research Monitoring Specialist

Arkansas Children's; Little Rock (AR); On-site; USD 52,000 - 78,000; Full time

Job summary

Arkansas Children's in Little Rock is seeking a Research Integrity monitor to oversee compliance for human studies. The role includes reviewing case report forms, source documents, regulatory documents, and ensuring secure study records and proper informed consent processes.

The position requires a high school diploma or GED with 2 years of relevant experience (or 4 years in lieu). A Bachelor's degree in a related field is preferred and SOCRA CCRP or ACRP-CP certifications are advantageous.

Qualifications

• High School Diploma or GED and 2 years of relevant experience, or 4 years of experience in lieu of a diploma/GED.
• Bachelor's degree in a related field preferred.

Responsibilities

• Develop, implement, and maintain a monitoring program and tools for human research.
• Obtain documents and assure the files are complete.
• Conduct initial, interim and close-out monitoring visits for all designated studies.
• Communicate issues and status of monitoring activities, potential findings, and education opportunities.
• Reviews contracts for required elements.
• Develop procedures, tools, internal systems trend analyses, quality improvement efforts and monitor its effect.
• Assist in educational activities/training, coordinate trends in audits, and be a content resource.
• Assist research project development, drafting forms, and reviewing documents.
• Other duties as assigned

Education

SOCRA CCRP certification

ACRP-CP certification

High School diploma or GED

Bachelor's degree in related field

Job description

ARKANSAS CHILDREN'S IS A TOBACCO FREE WORKPLACE. FLU VACCINES ARE REQUIRED. ARKANSAS CHILDREN'S IS AN EQUAL OPPORTUNITY EMPLOYER. ALL QUALIFIED APPLICANTS WILL RECEIVE CONSIDERATION FOR EMPLOYMENT WITHOUT REGARD TO RACE, COLOR, RELIGION, SEX, SEXUAL ORIENTATION, GENDER IDENTITY OR EXPRESSION, NATIONAL ORIGIN, AGE, DISABILITY, PROTECTED VETERAN STATUS OR ANY OTHER CHARACTERISTIC PROTECTED BY FEDERAL, STATE, OR LOCAL LAWS.

This position has been designated as safety sensitive and cannot be filled by a candidate who is a current user of medical marijuana.

Work Shift

Day Shift

Time Type

Full time

Department

CC033007 Research Integrity

Summary

Responsible for monitoring activities to assure compliance. Provides reviews of case report forms, source documents, and regulatory documents; assesses the maintenance and security of study records, test articles, and study specimens; reviews the informed consent process; and serves as an institutional liaison.

Preferred Qualifications

• SOCRA CCRP certification or ACRP-CP certification

Required Education

High school diploma or GED or equivalent

Recommended Education

Bachelor's degree in a related field of study.

Required Work Experience

High School Diploma/GED and 2 years of relevant experience, or 4 years of experience in lieu of a diploma/GED.

Description

• Develop, implement, and maintain a monitoring program and tools for human research.
• Obtain documents and assure the files are complete.
• Conduct initial, interim and close-out monitoring visits for all designated studies.
• Communicate issues and status of monitoring activities, potential findings, and education opportunities.
• Reviews contracts for required elements.
• Develop procedures, tools, internal systems trend analyses, quality improvement efforts and monitor its effect.
• Assist in educational activities/training, coordinate trends in audits, and be a content resource.
• Assist research project development, drafting forms, and reviewing documents.
• Other duties as assigned