ASSOCIATE DIRECTOR RESEARCH INTEGRITY

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Job description

This position reports to the Director of the Office of Research and Sponsored Programs and the Research Compliance Officer. 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. Develops and maintains positive, collaborative relationships with the research community to facilitate compliance.

Responsibilities:

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. Provide input to monitor and amend the annual plan as necessary. Audit selected research by performing on site review 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 (CAPA's for feasibility and inclusion of all required corrective activities. Monitor the implementation of CAPAs to ensure that all identified issues are implemented in a timely manner.

Perform auditing of the IRB as directed. 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. Serve as subject matter expert with respect to FDA and OHRP audits. Provide support and assistance to researchers responding to external audit findings

Perform timely reporting of all audit findings to research leadership and the applicable IRB. In instances of non compliance educate research staff on applicable state and federal regulations. Submit audit findings to Director to ensure quality and consistency of results. Identify escalate and manage all matters that require institutional input or responses. Utilize appropriate metrics

EDUCATION/REQUIREMENTS:

Bachelors degree. 3 -5 years clinical research experience required. Experience in clinical research quality assurance, monitoring or auditing on industry/NIH funded clinical trial in 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 feral 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 collection of 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 to work effectively with all levels of staff.

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Diversity, equity and inclusion are core values of Montefiore. We are committed to recruiting and creating an environment in which associates feel empowered to thrive and be their authentic selves through our inclusive culture. We welcome your interest and invite you to join us.

Montefiore is an equal employment opportunity employer. Montefiore will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.

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