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Clinical Research Coordinator (Dual Post linked with Job ID 54742 - Clinical Research Nurse)

University of Missouri-Columbia
parental leave, paid time off
United States, Missouri, Columbia
801 Conley Avenue (Show on map)
Feb 13, 2025
Hiring Department

The University of Missouri School of Medicine Medical Research Department.

Job Description

(This position is a dual post linked with Job ID 54742 - Clinical Research Nurse, and the department will be hiring one candidate. Finial or offered title will be determined by qualifications of the candidate.)

The primary function of the Clinical Research Coordinator is to provide both technical and administrative clinical research support and coordination of clinical trials in the Clinical and Translational Science Units in the NextGen Precision Health building (CTSU East) and the School of Medicine/Hospital space (CTSU West).

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 Phase I-IV 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.

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.

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 Nurse Manager. 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.

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.

Work with Office of Medical Research business support staff and Hospital/University Physicians billing staff to ensure correct charges for clinical research services and other project expenses. Identify quality and performance improvement opportunities. Participate in the development and implementation of action plans to improve quality.

Shift

Shift Type: Monday through Friday 8am - 5pm, with occasional other hours as required by study protocols

Flexibility for Alternative Schedules: No

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

Preferred certification in clinical research by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Professionals (SOCRA).

Anticipated Hiring Range

Hiring Range: $51,875 - $88,000
Grade: GGS-010
University Title: RESEARCH CONSULTANT
Internal applicants can determine their university title by accessing the Talent Profile tile in myHR.

Application Materials

In addition to filling out the online application please provide a Resume.

Community Information

Columbia offers small-town friendliness with big city features and a high quality of life for people of all ages and interests. Founded on education and known as an ideal college town, its location also makes it an attractive spot for businesses and travelers. Located on Interstate 70 and U.S. Highway 63, Columbia is right in the middle of the state and the nation. Just a couple hours' drive from St. Louis and Kansas City, Columbia is Boone County's largest population center offering big-city culture, activities, and resources with a low cost of living. Columbia is home to a variety of restaurants and entertainment venues and hosts more than a dozen cultural festivals each year. If you want to grow your career, continue your education, raise a family, and retire, Columbia is a good place to be!

Benefit Eligibility

This position is eligible for University benefits. As part of your total compensation, the University offers a comprehensive benefits package, including medical, dental and vision plans, retirement, paid time off, short- and long-term disability, paid parental leave, paid caregiver leave, and educational fee discounts for all four UM System campuses. For additional information on University benefits, please visit the Faculty & Staff Benefits website at https://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

The University of Missouri System is an Equal Opportunity Employer. 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, or protected veteran status, or any other status protected by applicable state or federal law. This policy applies to all employment decisions including, but not limited to, recruiting, hiring, training, promotions, pay practices, benefits, disciplinary actions and terminations. For more information, visit https://www.umsystem.edu/ums/hr/eeo or call the Director of Employee and Labor Relations at 573-882-2146.

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

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