Program Manager Clinical Research

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The Clinical ResearchProgramManager- Monitor, under the supervision of the Director of Quality Assurance, will provide compliance and quality assurance reviews for the Montefiore Einstein Cancer Clinical Trials Office. The Clinical ResearchProgramManager- Monitor will be responsible for all ongoing monitoring activities -patient case reviews, pharmacy reviews, regulatory reviews for Montefiore Einstein Cancer Center Investigator Initiated Trials (trials where MECC clinicians are the Sponsor Investigators/IND Holder). The CRM will provide routine reviews and determine if there are compliance concerns that warrant a formal of the trials. The duties of this position must be executed in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), the Montefiore Einstein Cancer Center Data and Safety Monitoring Plan (DSMP), and any other applicable regulatory requirements.

The Clinical ResearchProgramManager- Monitor will work under the direction of the Director, Quality Assurance and will provide constant feedback on findings and evaluation of instituted Corrective and Preventative Action Plans (CAPA).

The Clinical ResearchProgramManager- Monitor will serve as the Administrator for the MECC Data and Safety Monitoring Committee.

In addition, the Clinical ResearchProgramManager- Monitor will work with the Director, Quality Assurance to develop and support an eligibility review process for all patients enrolled on cancer clinical studies.

Requirements

Bachelor's degree requires, Master's degree preferred

5 years of work experience required

Minimum of 3 years of experience in clinical research

CCRP/CCRC Certification preferred

Prior experience with internal audits and/or FDA inspection preparations.

Demonstrated knowledge proficiency of and adherence to federal (FDA, OHRP, GCP, etc.), state, and other regulatory standards, requirements, and guidelines related to clinical research

Strong working knowledge of ongoing monitoring techniques (including criteria development and trending)
Strong working knowledge of quality management principles, tools, and risk management techniques

Analytical and critical thinking skills to recognize trends
Demonstrated ability to manage projects: ability to prioritize, identify barriers and meet deadlines
Ability to prioritize, organize, plan, and implement services as well as handle multiple projects/problems simultaneously

Demonstrated communication, leadership, and team building skills: evidence of this should include dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others

Demonstrated skill in working with minimal supervision

Effective written and verbal communication