Executive Director, Human Research Protection & Compliance

first_imgSome Job ResponsibilitiesDevelops the strategy and approach for the Human ResearchProtection & Compliance office under the direction of theAssistant Dean for Clinical Research Compliance/InstitutionalOfficial for Human Research Protections.Responsibilities include, but are not limited to, overallfiscal management, workforce management, identifying issues ofconcern in the respective areas covered by offices and implementingpolicy and procedure program improvements.Develops and promulgates WCM policies regardingreview/oversight of research involving human subjects, humanembryonic stem cell research and human research compliance,ensuring consistency with federal, NYS/local and otherregulations.Serves as the key institutional expert on regulatory andcompliance matters as it relates to human subjects research.Directs appropriate internal resources to create transparentand actionable metrics for all functions of the HRPP that measureperformance and process improvement; develops and refineshigh-level quality improvement strategies.Prepares and presents reports and summaries to institutionalleadership, Meyer cancer center leadership, IRBs and/or researchcommunity as appropriate.Serves in leadership role with communications between WCM andthe FDA, Office of Civil Rights, Office for Human ResearchProtections, federal Office of Research Integrity, federal andnon-federal funding agencies, and other external entities.Serves as the Human Protections Administrator on the WCMFederal wide Assurance document for WCM New York, with the USDepartment of Health and Human Services. Experience:Master’s Degree is highly desired.Approximately 10 years of experience working in an establishedinstitutional research administration setting, including experiencedirectly related to IRB administration and operations, researchcompliance, and responsible conduct of research, preferably in anacademic or health sciences setting.Experience in managing a regulatory office with professionalstaff.Extensive knowledge of the current federal regulations relatedto research, including human subjects’ research, conflicts ofinterest and the new “common rule.”Management experience with direct oversight and responsibilityfor staff, including performance. Knowledge, Skills and AbilitiesMaintains knowledge of current federal and universityregulations and guidelines.Strong interpersonal and institutional, written and oralcommunication skills, and the ability to relate to adversity ofpeople and institutions are essential.Ability to effectively communicate to individuals at alllevels.Capable of working collaboratively with others to meetobjectives.Ability to secure support from faculty, administrators, andstaff. The WCM IRB is an appropriately constituted group whose primaryresponsibility is to ensure that the rights and welfare of humansubjects in research are protected. In doing so, the IRB mustensure all human subject research activities are conductedethically, and in compliance with Federal regulations, therequirements of applicable New York State and local law, andinstitutional policies and procedures. In accordance with theCommon Rule and FDA regulations, the IRB has responsibility forapproving, modifying, and/or disapproving human subject research.The IRB also has the authority to suspend or terminate research inorder to protect research subjects and for noncompliance withapplicable rules and regulations. The Executive Director for Human Research Protection andCompliance reports directly to the Assistant Dean forClinical Research Compliance/Institutional Official for HumanResearch Protections, with a “dotted line” reporting to theInstitutional Chief Research Compliance Officer. Providesoversight, direction and integrative coordination in the planning,development and implementation of the Weill Cornell Medical CollegeHuman Research Protection Program (WCM HRPP). The major domainswithin the Human Research Protection Program include the IRBoffice, DSMC (Data and Safety Monitoring Committees),Tri-Institutional ESCRO (Embryonic Stem Cell Research Oversight),research education and review (for cause auditing, education of theresearch community on regulatory and compliance matters) and othercompliance areas such as CT.gov. This role is the face of, andadvocate for, human research protections both within and outsideWCMC. In addition, this role cultivates and leads an institutionalculture of compliant and ethical research involving humansubjects. To apply, please visithttp://appl.ink/a164692center_img Weill Cornell Medicine is committed to excellence in patientcare, scientific discovery and the education of future physiciansin New York City and around the world. Since 1898, our doctors andscientists have been engaged in world-class clinical care andcutting-edge research that connect patients to the latest treatmentinnovations and prevention strategies. Executive Director, HumanResearch Protection & Compliance (48543) Education: Bachelor’s degree Weill Cornell Medicine is a comprehensive academic medicalcenter that’s committed to excellence in patient care, scientificdiscovery, and the education of future physicians in New York Cityand around the world. Our doctors and scientists-faculty from WeillCornell Medical College, Weill Cornell Graduate School of MedicalSciences, and the Weill Cornell Physician Organization-are engagedin world-class clinical care and cutting-edge research that connectpatients to the latest treatment innovations and preventionstrategies. Located in the heart of the Upper East Side’sscientific corridor, Weill Cornell Medicine’s powerful network ofcollaborators extends to its parent university Cornell University;to Qatar, where an international campus offers a U.S. medicaldegree; and to programs in Tanzania, Haiti, Brazil, Austria andTurkey. Our medical practices serve communities throughout New YorkCity, and our faculty provide comprehensive care atNewYork-Presbyterian Hospital/Weill Cornell Medical Center,NewYork-Presbyterian/Lower Manhattan Hospital, andNewYork-Presbyterian/Queens. At Weill Cornell Medicine, we worktogether to treat each individual, not just their conditions orillnesses, as we strive to deliver the finest possible care for ourpatients – the center of everything we do. Weill Cornell Medicineis an Equal Employment Opportunity Employer. Weill Cornell Medicineprovides equal employment opportunities to all qualified applicantswithout regard to race, sex, sexual orientation, gender identity,national origin, color, age, religion, protected veteran ordisability status, or genetic information.last_img read more