University of Missouri-Columbia
Regulatory Affairs Coordinator
University of Missouri-Columbia, Columbia, Missouri, United States, 65201
Hiring Department
The UM SOM Department of Medical Research. Job Description
This position supports clinical research/trials at the University of Missouri, primarily in the start-up phase (regulatory documents, IRB submissions, etc.), acting as the IRB/Regulatory Start-Up specialist for MU SOM. In addition, this position acts as the ClinicalTrials.gov Administrator for MU, ensuring that study records are being updated appropriately (per FDAAA 801) and providing MU SOM researchers support when necessary. Responsibilities for this position also include the creation and maintenance of educational/onboarding/offboarding material for MU SOM clinical research staff. This position will provide administrative support for clinical research FDA investigational new drug (IND) applications and clinical research FDA investigational device exemptions (IDE). Major responsibilities:
*FDA IND and IDE applications, paperwork, correspondence, meetings with PIs. *Regulatory Start-Up: Completion of regulatory documents and paperwork, IRB applications. *UM SOM ClinicalTrials.gov administrator: Ensuring that study records are being updated appropriately (per FDAAA 801) and providing MU SOM researchers support when necessary. *Clinical research and trial feasibility forms for SOM. *Educational/Onboarding Material Creation. Shift
Shift Type: 8:00AM - 5:00PM, Monday - Friday Office/Administrative Hours: Yes - Position will have Office/Admin Hours
Minimum Qualifications
A Bachelor's degree or an equivalent combination of education and relevant experience, and at least 4 years of experience from which comparable knowledge and skills can be acquired is necessary. Preferred Qualifications
Preferred clinical research/trial professional certification (SOCRA/ACRP). Preferred regulatory affairs experience of at least one year.
Anticipated Hiring Range
Hiring Range: $58,573 - $80,880 Grade: GGS-011 University Title: RESEARCH CONSULTANT II 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.
The UM SOM Department of Medical Research. Job Description
This position supports clinical research/trials at the University of Missouri, primarily in the start-up phase (regulatory documents, IRB submissions, etc.), acting as the IRB/Regulatory Start-Up specialist for MU SOM. In addition, this position acts as the ClinicalTrials.gov Administrator for MU, ensuring that study records are being updated appropriately (per FDAAA 801) and providing MU SOM researchers support when necessary. Responsibilities for this position also include the creation and maintenance of educational/onboarding/offboarding material for MU SOM clinical research staff. This position will provide administrative support for clinical research FDA investigational new drug (IND) applications and clinical research FDA investigational device exemptions (IDE). Major responsibilities:
*FDA IND and IDE applications, paperwork, correspondence, meetings with PIs. *Regulatory Start-Up: Completion of regulatory documents and paperwork, IRB applications. *UM SOM ClinicalTrials.gov administrator: Ensuring that study records are being updated appropriately (per FDAAA 801) and providing MU SOM researchers support when necessary. *Clinical research and trial feasibility forms for SOM. *Educational/Onboarding Material Creation. Shift
Shift Type: 8:00AM - 5:00PM, Monday - Friday Office/Administrative Hours: Yes - Position will have Office/Admin Hours
Minimum Qualifications
A Bachelor's degree or an equivalent combination of education and relevant experience, and at least 4 years of experience from which comparable knowledge and skills can be acquired is necessary. Preferred Qualifications
Preferred clinical research/trial professional certification (SOCRA/ACRP). Preferred regulatory affairs experience of at least one year.
Anticipated Hiring Range
Hiring Range: $58,573 - $80,880 Grade: GGS-011 University Title: RESEARCH CONSULTANT II 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.