PROGRAM MANAGER CLINICAL RESEARCH
: Job Details :

PROGRAM MANAGER CLINICAL RESEARCH (224363) Join to apply for the PROGRAM MANAGER CLINICAL RESEARCH (224363) role at Montefiore Health System PROGRAM MANAGER CLINICAL RESEARCH (224363) 5 days ago Be among the first 25 applicants Join to apply for the PROGRAM MANAGER CLINICAL RESEARCH (224363) role at Montefiore Health System Introduction To heal, to teach, to discover and to advance the health of the communities we serve. To learn more about the Montefiore Difference - who we are at Montefiore and all that we have to offer our associates, please click here . Overview The Clinical Research Program Manager- 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 Research Program Manager- 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. Responsibilities The Clinical Research Program Manager- 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 Research Program Manager- Will serve as the Administrator for the MECC Data and Safety Monitoring Committee. In addition, the Clinical Research Program Manager- 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 Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Project Management and Information Technology Industries Hospitals and Health Care Referrals increase your chances of interviewing at Montefiore Health System by 2x Sign in to set job alerts for Program Manager roles. 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