Clinical Research Coordinator

Hiring Department

Child Health

Job Description

• Coordinate research subject activities according to clinical trial protocol, applicable regulations, and ICH E6 R2 Good Clinical Practice (GCP) guidelines, and in a manner that maximizes subject retention on clinical trials. In collaboration with Principal Investigator and Clinical Research Nurse, review subjects for changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study intervention.
• Collect and document research data for human subject clinical trials. Responsible for accurate and timely source documentation and reporting of all pertinent aspects of protocol conduct and data in case report forms and sponsor electronic data capture systems. Work with investigators and study staff on clinical trial teams to ensure accurate and compliant records. Participate in the development of approved source documents and protocol tools to enhance clinical trial execution.
• Participate in feasibility analyses and program development in collaboration with principal investigators. Participate in and support sponsor site initiation visits and site auditing and monitoring visits, as well as internal monitoring visits. Prepare for COG site auditing visits (that occur every 3 years).
• Participate in the informed consent process and enroll subjects to clinical trial protocols in accordance with eligibility criteria, as delegated by and under the direction of the Principal Investigator. Schedule and coordinate clinical research subject visits and ancillary tests and procedures according to protocol requirements.
• Provide technical support services to investigators and nurses, such as performing EKG, phlebotomy, clinical lab sample collection, processing and shipping samples per IATA regulations, and other technical and research tests/procedures. Responsible for collaboration and training of ancillary personnel, staff, and sub-investigators regarding protocol activities and procedures according to requirements.
• Coordinate regulatory activities, including required document maintenance. Prepare and submit Institutional Review Board applications and amendments for clinical research protocols under the guidance of the Principal Investigator and Research Nurse. Ensure relevant documentation is provided to Institutional Review Boards (local and central) as delegated by Principal Investigator. Prepare, maintain, and submit clinical trial regulatory documents to grant funding agencies and commercial sponsors in compliance with institutional and sponsor regulations and requirements.

• Coordinate research subject activities according to clinical trial protocol, applicable regulations, and ICH E6 R2 Good Clinical Practice (GCP) guidelines, and in a manner that maximizes subject retention on clinical trials. In collaboration with Principal Investigator and Clinical Research Nurse, review subjects for changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study intervention.
• Collect and document research data for human subject clinical trials. Responsible for accurate and timely source documentation and reporting of all pertinent aspects of protocol conduct and data in case report forms and sponsor electronic data capture systems. Work with investigators and study staff on clinical trial teams to ensure accurate and compliant records. Participate in the development of approved source documents and protocol tools to enhance clinical trial execution.
• Participate in feasibility analyses and program development in collaboration with principal investigators. Participate in and support sponsor site initiation visits and site auditing and monitoring visits, as well as internal monitoring visits. Prepare for COG site auditing visits (that occur every 3 years).
• Participate in the informed consent process and enroll subjects to clinical trial protocols in accordance with eligibility criteria, as delegated by and under the direction of the Principal Investigator. Schedule and coordinate clinical research subject visits and ancillary tests and procedures according to protocol requirements.
• Provide technical support services to investigators and nurses, such as performing EKG, phlebotomy, clinical lab sample collection, processing and shipping samples per IATA regulations, and other technical and research tests/procedures. Responsible for collaboration and training of ancillary personnel, staff, and sub-investigators regarding protocol activities and procedures according to requirements.
• Coordinate regulatory activities, including required document maintenance. Prepare and submit Institutional Review Board applications and amendments for clinical research protocols under the guidance of the Principal Investigator and Research Nurse. Ensure relevant documentation is provided to Institutional Review Boards (local and central) as delegated by Principal Investigator. Prepare, maintain, and submit clinical trial regulatory documents to grant funding agencies and commercial sponsors in compliance with institutional and sponsor regulations and requirements.
• Assist with identifying and recruiting research subject participants for a variety of clinical research protocols. Responsible for prescreening, screening, and recruiting potential research subjects in accordance with eligibility requirements. Maintain and submit regular screening logs to sponsors. Organize and maintain recruitment files and research subject files.

Salary

Salary Range: $50,367 - $91,392

Grade: GGS - 010

University Title: RESEARCH CONSULTANT

Internal applicants can determine their university title by accessing the Talent Profile tile in myHR.

Shift

Monday – Friday

8:00 a.m. – 5:00 p.m.

Some weeknights or weekends necessary to ensure proper enrollment for clinic trials.

Minimum Qualifications

A Bachelor’s degree or an equivalent combination of education and relevant experience and at least 3 years of experience from which comparable knowledge and skills can be acquired is necessary.

Preferred Qualifications

Bachelor’s degree in health sciences, Science, Nursing, or Health Professions or at least 3 years of equivalent experience in clinical research or clinical trials experience; hospital, clinic, or similar health care setting. Certification in clinical research by Association of Clinical Research Professionals (ACRP) or
Society of Clinical Research Associates (SOCRA).

Application Materials

In addition to the Online Application, please provide a Cover Letter and Resume.

Columbia Missouri Information

Columbia, Mo., is known as an ideal college town, combining small-town comforts, community spirit and low cost of living with big-city culture, activities and resources. Home to nationally renowned public schools and other colleges and educational centers, Columbia is packed with restaurants and entertainment venues and hosts more than a dozen annual cultural festivals.

Benefit Eligibility

This position is eligible for University benefits. The University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, and educational fee discounts. For additional information on University benefits, please visit the Faculty & Staff Benefits website at http://www.umsystem.edu/totalrewards/benefits

Values Commitment

We value the uniqueness of every individual and strive to ensure each person’s success. Contributions from individuals with diverse backgrounds, experiences and perspectives promote intellectual pluralism and enable us to achieve the excellence that we seek in learning, research and engagement. This commitment makes our university a better place to work, learn and innovate.

In your application materials, please discuss your experiences and expertise that support these values and enrich our missions of teaching, research and engagement.

Equal Employment Opportunity

Equal Opportunity is and shall be provided for all employees and applicants for employment on the basis of their demonstrated ability and competence without unlawful discrimination on the basis of their race, color, national origin, ancestry, religion, sex, pregnancy, sexual orientation, gender identity, gender expression, age, disability, protected veteran status, or any other status protected by applicable state or federal law. This policy shall not be interpreted in such a manner as to violate the legal rights of religious organizations or the recruiting rights of military organizations associated with the Armed Forces or the Department of Homeland Security of the United States of America. For more information, call the Director of Employee and Labor Relations at 573-882-7976.

To request ADA accommodations, please call the Director of Accessibility and ADA at 573-884-7278.

Know Your Rights

To read more about Equal Employment Opportunity (EEO) please use the following links:

• Know Your Rights English Version
• Know Your Rights Spanish Version

Vaccination Statement

After careful consideration of COVID-19 virus trends and the overwhelming evidence of COVID-19 vaccine safety and effectiveness, the School of Medicine, along with MU Health Care, the Sinclair School of Nursing and the School of Health Professions, recently announced the decision to require COVID-19 vaccinations by Oct. 1, 2021, for all employees, unless granted a medical or religious exemption.

All new hires will be required to submit proof of vaccination prior to your start date. If you would like to request a medical or religious exemption, you must do so upon acceptance of employment so our team has time to review prior to your scheduled start date. You will not be allowed to begin work until you have submitted proof of vaccination or received an approved medical or religious exemption.

Thank you for helping us to create the safest environment possible for our colleagues, students and our patients by protecting yourself and others through COVID-19 vaccination.

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