This listing was posted on Montefiore Medical Center.
Program Manager Clinical Research- Quality Assurance
Location:
Bronx, NY
Description:
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. To learn more about the “Montefiore Difference” – who we are at Montefiore and all that we have to offer our associates, please click here . 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. #LI-KW1
Company:
Montefiore Medical Center
Posted:
April 17 on Montefiore Medical Center
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More About this Listing: Program Manager Clinical Research- Quality Assurance
Program Manager Clinical Research- Quality Assurance is a Executive Program Manager, QA Job at Montefiore Medical Center located in Bronx NY. Find other listings like Program Manager Clinical Research- Quality Assurance by searching Oodle for Executive Program Manager, QA Jobs.
Program Manager Clinical Research- Quality Assurance is a Executive Program Manager, QA Job at Montefiore Medical Center located in Bronx NY. Find other listings like Program Manager Clinical Research- Quality Assurance by searching Oodle for Executive Program Manager, QA Jobs.