Job Description
JOB SUMMARY:
Oversees and coordinates all day-to-day operations of the research compliance program, focusing on ensuring compliance with regulatory requirements, ethical principals, and institutional policies concerning the conduct of research. In general, this person will maintain a compliance program specific to research including developing and maintaining policies, developing training in collaboration with research personnel, auditing adherence to policies, laws, and regulations, and investigating instances of scientific misconduct. In particular, this position will strive to ensure that human subject protections are in place with each research protocol, and that each protocol contains appropriate financial controls to ensure proper billing, conflicts of interest disclosures, and grant application and reporting processes.
EDUCATIONAL REQUIREMENTS Masters degree in related field; bachelors degree in related field if accompanied by 8 years of research experience.
CERTIFICATION & LICENSURE REQUIREMENTS Certification in Healthcare Research Compliance (CHRC). Certification in Healthcare Research Compliance (CHRC) must be obtained within two (2) years of start date in position.
EXPERIENCE REQUIREMENTS Five (5) years in related field.
SKILLS AND KNOWLEDGE Knowledge of how clinical trials are conducted and administered in academic and/or hospital settings, including knowledge of federal and state laws and regulations relating to research in order to be able to monitor and audit protocol records for compliance. Thorough and highly detail oriented with a passion for research combined with a strong sense of integrity and ethics. Ability to communicate highly technical information to a variety of audiences.
ESSENTIAL FUNCTIONS:
- Provides guidance, information and education to researchers, staff, students, IRB members,and administrators regarding the interpretation and implementation of regulatory requirements related to research.
- Provides timely reports to leadership, applicable committees, andresearch staffon findings of reviews, including recommended corrective actions and training needs.
- Ensure compliance with all regulations, ethical principles and institutional policies related to the conduct of research.
- Conducts routine auditing and monitoring of existing research studies for human subject protections and billing compliance.
- This position comprises the function of Human Protections Administrator as described by the terms of the Federal Wide Assurance for institutions receiving federal funding for research purposes. In order to fulfill the role of Human Protections Administrator, the Research Integrity Officer must possess comprehensive knowledge of the institution's program for human subject protection in research.
- Oversees research conflict of interest program including completion of conflict of interest management plans when appropriate.
- Chairsthe research compliance committee.
- Meets regularly with IRB management and research administration regarding compliance-related issues.
- Provides guidance, information and education to researchers, staff, students, IRB members,and administrators regarding the interpretation and implementation of regulatory requirements related to research.
- Provides timely reports to leadership, applicable committees, andresearch staffon findings of reviews, including recommended corrective actions and training needs.
- Ensure compliance with all regulations, ethical principles and institutional policies related to the conduct of research.
- Conducts routine auditing and monitoring of existing research studies for human subject protections and billing compliance.
- This position comprises the function of Human Protections Administrator as described by the terms of the Federal Wide Assurance for institutions receiving federal funding for research purposes. In order to fulfill the role of Human Protections Administrator, the Research Integrity Officer must possess comprehensive knowledge of the institution's program for human subject protection in research.
- Oversees research conflict of interest program including completion of conflict of interest management plans when appropriate.
- Chairsthe research compliance committee.
- Meets regularly with IRB management and research administration regarding compliance-related issues.
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