Research Compliance Specialist 2015070
Work resides in the Office of Clinical Research (OCR) reporting to the OCR Manager. Interfaces extensively with the OCR, IRB, IACP, CTO staff and other departments. He/she ensures the institution's compliance with policies and regulations regarding the use of human subjects and laboratory animals in research.
Conducts highly competent review of research applications to assess risks to the institution and identify the regulatory and institutional policy requirements. Communicates training requirements and Research Scope of Practice requirements to research staff as they relate to specific protocols and verifies requirements are satisfied prior to issuing institutional approvals for research implementation.
Coordinates with affiliated institutions, clinical departments, other institutional committees and departments to facilitate institutional approvals to achieve rapid enrollment of participants into clinical research trials.
Processes incoming business items to ensure necessary documents are present and items are then put into the workflow for appropriate and timely review.
Communicates the outcomes of the reviews to the investigators and institutions. Maintains accurate documentation of all actions and determinations made related to the research studies.
Provides advice and assistance to investigators, committee members, office staff, and research staff regarding procedural requirements for submitting research materials and documents to ensure compliance to the applicable regulations and policies.
Associate's degree in Clinical Research, or other relevant field, or at least four (4) years of functional research regulatory experience; Bachelor's degree is preferred.
Preferred
Qualifications:
Significant working knowledge of complex Federal, State and Local research and HIPAA related regulations. Possess excellent verbal and written communications skills. Ability to multitask and set priorities in a highly demanding environment involving multiple overlapping processes. Work experience within a large organization with multiple affiliate organizations, such as an academic health center.Estimated Salary: $20 to $28 per hour based on qualifications.
Conducts highly competent review of research applications to assess risks to the institution and identify the regulatory and institutional policy requirements. Communicates training requirements and Research Scope of Practice requirements to research staff as they relate to specific protocols and verifies requirements are satisfied prior to issuing institutional approvals for research implementation.
Coordinates with affiliated institutions, clinical departments, other institutional committees and departments to facilitate institutional approvals to achieve rapid enrollment of participants into clinical research trials.
Processes incoming business items to ensure necessary documents are present and items are then put into the workflow for appropriate and timely review.
Communicates the outcomes of the reviews to the investigators and institutions. Maintains accurate documentation of all actions and determinations made related to the research studies.
Provides advice and assistance to investigators, committee members, office staff, and research staff regarding procedural requirements for submitting research materials and documents to ensure compliance to the applicable regulations and policies.
Associate's degree in Clinical Research, or other relevant field, or at least four (4) years of functional research regulatory experience; Bachelor's degree is preferred.
Preferred
Qualifications:
Significant working knowledge of complex Federal, State and Local research and HIPAA related regulations. Possess excellent verbal and written communications skills. Ability to multitask and set priorities in a highly demanding environment involving multiple overlapping processes. Work experience within a large organization with multiple affiliate organizations, such as an academic health center.Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
