Regulatory Coordinator – IRB Specialist

Full Time
Columbia, MO
Posted
Job description

Hiring Department


Ellis Fischel Cancer Center Clinical Trials Office

Job Description


Under general supervision, communicates complex medical information in clear, concise and compliant writing. Compile, write and edit clinical research information for submission to regulatory bodies and Institutional Review Boards. This position serves as a key interface between sponsors and Institutional Review Boards, requiring a working knowledge of federal regulations and International Council for Harmonization Good Clinical Practice guidelines relative to clinical research. The position requires the ability to write technical documents (protocols, protocol-related documents including patient-oriented documents such as informed consent documents).

Key Responsibilities
  • Responsible for coordinating and managing all IRB submissions for the Clinical Trials Office. This includes all IRB applications, amendments, continuing reviews, miscellaneous submissions and correspondence.
  • Medical writing: generates study documents (Informed Consent Documents, other protocol-related documents. Participates in protocol writing as required).
  • Responsible for the maintenance of all documentation of IRB activity in a timely, organized and professional manner. Ensures compliance with all applicable regulations, policies, and guidelines.
  • Interacts with study sponsors, IRBs, site personnel and other research entities regarding regulatory / study related issues and to assure full compliance with regulations and ICH GCP guidelines.
  • May participate in generating and maintaining study startup and essential documentation, including collecting, processing and maintaining staff licensure, CVs, training records, and other required documentation required for clinical research.
  • May assist with administrative functions of the Clinical Trials Office, triages phone calls, coordinates meetings, coordinates information exchange among team members.
  • May coordinate training of and mentor other research staff.

Salary


Salary Range: $17.43 - $32.21 hourly

Grade: GGS - 008

University Title: RESEARCH SPECIALIST II

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.

Occasional other hours, including evenings, or weekends, as required by study protocols or workload.

Minimum Qualifications


Bachelor's degree or an equivalent combination of education and relevant experience and at least 1 year of experience from which comparable knowledge and skills can be acquired is necessary.

Preferred Qualifications


Two years’ experience in medical field, preferably in oncology. Must possess sound knowledge of medical terminology. Minimum of one year in clinical research, preferably in oncology.
Preferred 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 list of references 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

Diversity Commitment

The University of Missouri is fully committed to achieving the goal of a diverse and inclusive academic community of faculty, staff and students. We seek individuals who are committed to this goal and our core campus values of respect, responsibility, discovery and excellence.

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 573-884-2577.

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

EEO IS THE LAW

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

  • EEO is the Law English Version
  • EEO is the Law Spanish Version
  • EEO is the Law Chinese 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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