Dir, Human Rsch Protection Pgm
The Dir, Human Rsch Protection Pgm responsibility for the Organization's distributed program for protecting human participants in research. The Director will establish all aspects of the organization's system of protections for research participants. This role will be responsible for the Associate for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation process and is responsible for overseeing a range of research integrity/compliance functions, including but not limited to: animal care and use, protection of human subjects, management of conflicts of interest, research involving biohazardous agents and rDNA, responsible conduct of research and export control. This position will also oversee the process for aligning the multiple IRB systems in the Meridian Health Network into one system under the designated Human Research Protection Program.
- The Director serves as the primary contact for Office for Human Research Protections (OHRP) regarding human research protection issues for the organization. The Director has responsibility for the organization's distributed program for protecting human participants in research and plays a key role in ensuring that the organization fulfills its responsibilities under the Federal Wide Assurance (FWA).
- Maintain organization’s Federal Wide Assurance (FWA) and ensure compliance with its terms, as well as HMH’s policies and procedures, federal regulations, and state and local laws relative to the conduct of human research studies.
- Develop and implement human research protection policies and procedures adhering to AAHRPP standards
- Oversee and coordinate HRPP activities across the various offices and staff that have roles in protecting research participants.
- Oversee the quality assurance monitoring of the HRPP, including research protocols and investigation of matters of non-compliance. Ensure implementation of corrective action, as needed, in accordance with the Organization’s HRPP policies and procedures.
- Monitor federal regulatory websites and other research-related resources so as to stay current with regulatory changes in human research protections guidelines and policies.
- Leads the organization's process for evaluating, managing, and monitoring research conflicts of interests. Serves as the Conflict of Interest Officer.
- Serves as the Research Integrity Officer (RIO) who oversees procedure, documentation, federal reporting, preliminary assessment, and inquiry of adverse research events and research misconduct.
- Evaluate research programs and leverages technology to develop systems that ensure compliance coordinate vendor relations.
- Receives and triages complaints from the research community.
- Provides technical consultation to the boards concerning review of ethically and scientific complex research involving vulnerable clients and patient populations and sensitive research.
- Represent the medical center in audits and deliberations with federal, state, and local agencies and organizations.
- Supervises ethical and technical review of proposals meeting criteria for exempt and expedited review.
- Coordinates with grant and contract services regarding compliance on new, continuing, and competing proposals with human subjects’ regulation policies.
- Bachelor’s degree.
- Minimum of 10 years clinical research experience.
- Knowledge of research regulations required.
- Strong background in regulatory affairs and management.
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