Executive Director, Human Research Protection & Compliance

Location
New York, United States
Salary
Salary Not specified
Posted
Apr 12, 2021
Employment Level
Executive
Employment Type
Full Time

Executive Director, Human Research Protection & Compliance (48543)

 

Weill Cornell Medicine is committed to excellence in patient care, scientific discovery and the education of future physicians in New York City and around the world. Since 1898, our doctors and scientists have been engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies.

 

The WCM IRB is an appropriately constituted group whose primary responsibility is to ensure that the rights and welfare of human subjects in research are protected. In doing so, the IRB must ensure all human subject research activities are conducted ethically, and in compliance with Federal regulations, the requirements of applicable New York State and local law, and institutional policies and procedures. In accordance with the Common Rule and FDA regulations, the IRB has responsibility for approving, modifying, and/or disapproving human subject research. The IRB also has the authority to suspend or terminate research in order to protect research subjects and for noncompliance with applicable rules and regulations.

 

The Executive Director for Human Research Protection and Compliance reports directly to the Assistant Dean for Clinical Research Compliance/Institutional Official for Human Research Protections, with a “dotted line” reporting to the Institutional Chief Research Compliance Officer. Provides oversight, direction and integrative coordination in the planning, development and implementation of the Weill Cornell Medical College Human Research Protection Program (WCM HRPP). The major domains within the Human Research Protection Program include the IRB office, DSMC (Data and Safety Monitoring Committees), Tri-Institutional ESCRO (Embryonic Stem Cell Research Oversight), research education and review (for cause auditing, education of the research community on regulatory and compliance matters) and other compliance areas such as CT.gov. This role is the face of, and advocate for, human research protections both within and outside WCMC. In addition, this role cultivates and leads an institutional culture of compliant and ethical research involving human subjects.

 

Some Job Responsibilities

  • Develops the strategy and approach for the Human Research Protection & Compliance office under the direction of the Assistant Dean for Clinical Research Compliance/Institutional Official for Human Research Protections.
  • Responsibilities include, but are not limited to, overall fiscal management, workforce management, identifying issues of concern in the respective areas covered by offices and implementing policy and procedure program improvements.
  • Develops and promulgates WCM policies regarding review/oversight of research involving human subjects, human embryonic stem cell research and human research compliance, ensuring consistency with federal, NYS/local and other regulations.
  • Serves as the key institutional expert on regulatory and compliance matters as it relates to human subjects research.
  • Directs appropriate internal resources to create transparent and actionable metrics for all functions of the HRPP that measure performance and process improvement; develops and refines high-level quality improvement strategies.
  • Prepares and presents reports and summaries to institutional leadership, Meyer cancer center leadership, IRBs and/or research community as appropriate.
  • Serves in leadership role with communications between WCM and the FDA, Office of Civil Rights, Office for Human Research Protections, federal Office of Research Integrity, federal and non-federal funding agencies, and other external entities.
  • Serves as the Human Protections Administrator on the WCM Federal wide Assurance document for WCM New York, with the US Department of Health and Human Services.

 

Education: Bachelor’s degree

 

Experience:

  • Master’s Degree is highly desired.
  • Approximately 10 years of experience working in an established institutional research administration setting, including experience directly related to IRB administration and operations, research compliance, and responsible conduct of research, preferably in an academic or health sciences setting.
  • Experience in managing a regulatory office with professional staff.
  • Extensive knowledge of the current federal regulations related to research, including human subjects’ research, conflicts of interest and the new “common rule.”
  • Management experience with direct oversight and responsibility for staff, including performance.

 

Knowledge, Skills and Abilities

  • Maintains knowledge of current federal and university regulations and guidelines.
  • Strong interpersonal and institutional, written and oral communication skills, and the ability to relate to adversity of people and institutions are essential.
  • Ability to effectively communicate to individuals at all levels.
  • Capable of working collaboratively with others to meet objectives.
  • Ability to secure support from faculty, administrators, and staff.

 

To apply, please visit

http://appl.ink/a164692

 

Weill Cornell Medicine is a comprehensive academic medical center that's committed to excellence in patient care, scientific discovery, and the education of future physicians in New York City and around the world. Our doctors and scientists-faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and the Weill Cornell Physician Organization-are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies. Located in the heart of the Upper East Side's scientific corridor, Weill Cornell Medicine's powerful network of collaborators extends to its parent university Cornell University; to Qatar, where an international campus offers a U.S. medical degree; and to programs in Tanzania, Haiti, Brazil, Austria and Turkey. Our medical practices serve communities throughout New York City, and our faculty provide comprehensive care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian/Lower Manhattan Hospital, and NewYork-Presbyterian/Queens. At Weill Cornell Medicine, we work together to treat each individual, not just their conditions or illnesses, as we strive to deliver the finest possible care for our patients - the center of everything we do. Weill Cornell Medicine is an Equal Employment Opportunity Employer. Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.

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