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 will be responsible for all ongoing monitoring activities including patient case reviews, pharmacy reviews, and regulatory reviews for Montefiore Einstein Cancer Center Investigator Initiated Trials (trials where MECC clinicians are the Sponsor Investigators/IND Holder).

The role will provide routine reviews and determine if there are compliance concerns that warrant a formal review of the trials. All duties 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.

Location and Schedule

• •Location: Bronx, New York
• •Department: Cancer Clinical Trials Office
• •Work Days: Monday through Friday
• •Hours: 9 AM to 5:30 PM (7.5 hours daily)
• •Pay Range: $84,000 to $105,000
• •Grant Funded: Yes

Responsibilities

• •Work under the direction of the Director of Quality Assurance and 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 of Quality Assurance to develop and support an eligibility review process for all patients enrolled on cancer clinical studies
• •Conduct ongoing monitoring activities including patient case reviews, pharmacy reviews, and regulatory reviews
• •Identify compliance concerns and determine when formal reviews of trials are warranted
• •Ensure adherence to GCP guidelines, SOPs, DSMP, and applicable regulatory requirements

Requirements

• •Bachelor's degree required, master's degree preferred
• •5 years of overall work experience required
• •Minimum of 3 years of experience in clinical research
• •CCRP or CCRC certification preferred
• •Prior experience with internal audits and/or FDA inspection preparations
• •Demonstrated knowledge of federal (FDA, OHRP, GCP) and state regulatory standards 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, prioritize, identify barriers, and meet deadlines
• •Ability to handle multiple projects and problems simultaneously
• •Demonstrated communication, leadership, and team building skills
• •Ability to work with minimal supervision
• •Effective written and verbal communication skills