Office of Research Integrity Administrator

: MedStar Health Research Institute is actively recruiting for an experienced research professional to join our team in the role of Office of Research Integrity (ORI) Administrator to assist with and perform administrative functions related to the regulatory and ethical review process for regulatory committees overseen by ORI. The incumbent independently performs reviews of research protocols submitted to the regulatory committees. The incumbent is primarily responsible for administrative and analytical analysis of submissions, checking for completeness and compliance with ethical and regulatory requirements and MHRI policies. The incumbent acts as a resource to investigators, clinical staff, research coordinators, and administrators in their preparation and performance of ongoing research activities. The incumbent facilitates and encourages open communication between researchers, the Office of Research Integrity and regulatory committees. The incumbent is responsible for assuring timely review and processing of protocols in accordance with applicable federal regulations and ORI Standard Operating Procedures (SOPs). Education

• Bachelor's degree required
• Master's degree preferred
• Directly related work experience may be considered in lieu of degree: CIP certification and 3 years direct experience with IRB/IACUC or other research administration environment required

Experience

• Understanding the requirements governing research involving potentially hazardous biologics, including recombinant DNA and SNA, infectious agents, and biological toxins required
• 3-4 years experience directly relating to research administration required
• Working knowledge of research and/or medical terminology and IRB: knowledge of federal regulations such as 21 CFR 50, 56, and 312; 45 CFR 46, 45 CFR 164, etc; all relevant and applicable federal regulations required
• Must understand and be able to apply ethical, legal and regulatory requirements for the protection of human subjects in research and understanding of AAHRPP accreditation standards required
• Knowledge of medical and scientific terminology and research conduct and previous IRB experience required
• IACUC: knowledge of animal welfare act as amended (Public law 99-198 - the improved standard for laboratory animals act), guide for the care and use of laboratory animals (8th ed.) and the guide for the care and use of agricultural animals in research and teaching preferred
• Understanding of association for assessment and accreditation of laboratory animal care (aaalac) accreditation standards. Must understand and apply ethical, legal and regulatory requirements for animal care and use in research required
• IBC: Knowledge of NIH guidelines. understanding the requirements governing research involving potentially hazardous biologics, including recombinant DNA and SNA, infectious agents, and biological toxins required

Licenses and Certifications

• CIP (Certified IRB Professional) required within 12 months from date of hire.

Knowledge, Skills, and Abilities

• Demonstrated proficiency required in Regulatory knowledge, customer service, written and verbal communications, Prioritization of tasks, implementation and follow-up of all tasks associated with responsibilities.
• Advanced computer skills, including Microsoft Office, with emphasis on Access, Sharepoint, Excel and Word.
• Prior experience with ORI IRB/IACUC software preferred.
• Ability to use multiple software programs and adapt to different database programs.
• Must possess attention to detail, excellent verbal, written, and analytic skills.
• Mature professional judgment and effective problem resolution skills required.
• Ability to work collegially and effectively in a wide variety of roles.
• Self-motivated, able to set priorities and work independently yet within a collaborative environment, ability to coordinate multiple activities concurrently in a deadline-oriented environment.
• Excellent interpersonal skills and personal integrity to handle situations effectively and in a positive manner.
• Commitment to respect privacy and confidentiality.