Associate Director of Research Integrity

2 days ago

Bronx, New York, United States MONTEFIORE MEDICAL CENTER Full time
Job Title: Associate Director Research Integrity

This position reports to the Director of the Office of Research and Sponsored Programs and the Research Compliance Officer. The Associate Director of Research Integrity is responsible for ensuring adherence with Federal, State, and local regulations and institutional policies in the conduct of research through auditing and monitoring clinical research studies.

Key Responsibilities:
  • Develop and maintain positive, collaborative relationships with the research community to facilitate compliance.
  • Provide input in the development of audit policies and procedures, including development of the annual audit plan.
  • Participate in the selection of protocols for routine, educational, and for-cause site visits/audits.
  • Implement the annual audit plan and schedule, and provide input to monitor and amend the plan as necessary.
  • Audit selected research by performing on-site reviews for subject safety and protocol compliance with IRB, Federal, State, and local requirements.
  • Provide recommendations to investigators in the development of corrective and preventative action plans when required.
  • Review CAPAs for feasibility and inclusion of all required corrective activities, and monitor the implementation of CAPAs to ensure that all identified issues are implemented in a timely manner.
  • Perform auditing of the IRB as directed, and provide documentation and other support to Brany and other external IRBs in connection with their audits of clinical research at Montefiore.
  • Assist research teams with external audits as requested, and serve as a subject matter expert with respect to FDA and OHRP audits.
  • Provide support and assistance to researchers responding to external audit findings, and perform timely reporting of all audit findings to research leadership and the applicable IRB.
  • Identify, escalate, and manage all matters that require institutional input or responses, and utilize appropriate metrics.
Requirements:
  • Bachelor's degree.
  • 3-5 years of clinical research experience required.
  • Experience in clinical research quality assurance, monitoring, or auditing on industry/NIH-funded clinical trials in an academic medical center preferred.
  • Familiarity with Epic, RedCap, and Velos.
  • Familiarity with Microsoft Office and ability to learn custom web-based software.
  • Working knowledge of federal regulations for human research (21 CFR 50, 56, 312, and 812; 45 CFR 46).
  • Excellent organizational, interpersonal, time management, communication, and writing skills.
  • Ability to develop and lead educational programs, and to train groups and individuals.
  • Ability to exercise sound judgment and initiative in collecting information from a wide variety of sources.
  • Ability to work independently and in a team-oriented environment, develop relationships with the clinical research community, and work effectively with all levels of staff.

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