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CTRO Research Compliance Mgr

Description: The Research Compliance Manager is responsible for the research compliance program consisting of the following elements: 1) Internal Monitoring of Clinical Research Activities, and 2) Research Education, including; good clinical practice guidelines, human subject protection program requirements, and 3) Supports the ACH IRB with regard to documentation and compliance with federal regulations concerning informed consent of research subjects. This enables All Children's Hospital-Johns Hopkins Medicine to promote quality research integrity and compliance. The Research Compliance Manager under the direction of the Director of Research, and in collaboration with Legal Affairs and the IRB, is responsible for reviewing and monitoring informed consent documents, Investigator and other research related documents, along with providing education to the ACH research community to facilitate compliance with current laws, regulations, policies, procedures, and ethical standards.
Requirements: Specialized Minimum Qualifications: Bachelor’s Degree required in one of the following; nursing, healthcare, medical research, or healthcare related field. Prior experience in sponsored research or research compliance experience is required. Five years of demonstrated progressive leadership and management skills is required. Eligible for certification or current certification by professional organization in the area of research compliance/auditing/regulatory is preferred. Ability to work independently and exercise judgment necessary. Must have exceptional oral and written communication skills. Knowledge of Department of Health and Human Services and Food and Drug Administration regulations, medical terminology and human subject research necessary. Proficient computer skills required. Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information. Regular contact with physicians, other health care personnel and occasionally patients
Department: CTRO
Location: All Children's Hospital
Shift: 8 Hr, Day
Hours/Pay Period: 80
Requisition #: 14-507486-2015-05-0001

 

All Children's Hospital, a member of Johns Hopkins Medicine, is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, sex, age, national origin, disability, protected veteran status, or any other status protected by federal, state, or local law.

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