PROGRAM MANAGER CLINICAL RESEARCH- QUALITY ASSURANCE

The Clinical Research Program Manager- Monitor, under the supervision of the Assistant Director of Quality Assurance, will provide compliance and quality assurance reviews for the Montefiore Einstein Comprehensive Cancer Center Clinical Trials Office. The Clinical Research Program Manager- Monitor will be responsible for all ongoing monitoring activities -patient case reviews, pharmacy reviews, regulatory reviews for Montefiore Einstein Comprehensive Cancer Center Investigator Initiated Trials (trials where MECCC 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 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 Comprehensive Cancer Center Data and Safety Monitoring Plan (DSMP), and any other applicable regulatory requirements.

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

The Clinical Research Program Manager- Monitor, will serve as the Administrator for the MECCC Data and Safety Monitoring Committee.

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

Requirements

Bachelor's Degree, Required; Master's Degree, Preferred

5 years of work experience

Minimum 3 years of experience in clinical research.

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

CCRP/CCRC Certification preferred

Department: CANCER CLINICAL TRIALS OFFICE Bargaining Unit:Non UnionCampus:MOSES Employment Status:Regular Full-TimeAddress:1695 Eastchester Road, Bronx
Shift:DayScheduled Hours:9 AM-5:30 PMReq ID:218035Salary Range/Pay Rate:$71,250.00-$95,000.00

For positions that have only a rate listed, the displayedrate is the hiringrate but could be subject to change based on shift differential, experience, education or other relevant factors.

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