City/State:
Bronx, New York
Grant Funded:
Yes
Department:
Cancer Clinical Trials Office
Work Shift:
Day
Work Days:
MON-FRI
Scheduled Hours:
9 AM-5:30 PM
Scheduled Daily Hours:
7.5 HOURS
Pay Range:
$84,000.00-$105,000.00
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.
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).
Serve as the Administrator for the MECC Data and Safety Monitoring Committee.
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 required, 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
Montefiore Medical Center is an equal employment opportunity employer. Montefiore Medical Center 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.