PROGRAM MANAGER CLINICAL RESEARCH- QUALITY ASSURANCE
BRONX, NY, US
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 Union Campus: MOSES Employment Status: Regular Full-Time Address: 1695 Eastchester Road, Bronx
Shift: Day Scheduled Hours: 9 AM-5:30 PM Req ID: 218035 Salary Range/Pay Rate: $71,250.00 - $95,000.00
For positions that have only a rate listed, the displayed rate is the hiring rate but could be subject to change based on shift differential, experience, education or other relevant factors.
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