The Role
Manage QA and compliance monitoring for cancer clinical trials, conducting patient case, pharmacy, and regulatory reviews; administer the Data and Safety Monitoring Committee; develop eligibility review processes; evaluate findings and CAPAs; ensure adherence to GCP, SOPs, DSMP, and applicable regulatory requirements.
Summary Generated by Built In
City/State:
Bronx, New YorkGrant Funded:
YesDepartment:
Cancer Clinical Trials OfficeWork Shift:
DayWork Days:
MON-FRIScheduled Hours:
9 AM-5:30 PMScheduled Daily Hours:
7.5 HOURSPay Range:
$84,000.00-$105,000.00The 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
Skills Required
- Bachelor's degree
- Master's degree
- 5 years of work experience
- Minimum of 3 years of experience in clinical research
- CCRP/CCRC Certification
- Prior experience with internal audits and/or FDA inspection preparations
- Knowledge of federal, state, and other regulatory standards for clinical research (FDA, OHRP, GCP)
- Working knowledge of ongoing monitoring techniques, including criteria development and trending
- Working knowledge of quality management principles, tools, and risk management techniques
- Analytical and critical thinking skills to recognize trends
- Demonstrated project management skills, ability to prioritize and meet deadlines
- Ability to prioritize, organize, plan, and implement services and handle multiple projects simultaneously
- Demonstrated communication, leadership, and team building skills
- Ability to work with minimal supervision
- Effective written and verbal communication
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The Company
What We Do
Montefiore is one of New York’s premier academic health systems, renowned for its leading medical school, groundbreaking research and technology, and highly specialized, coordinated care for diverse populations in the New York region, across the country and globally. Visit Montefiore.org to learn more.
