Program Manager Clinical Research

About the role

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.

Responsibilities

• Provide compliance and quality assurance reviews for the Montefiore Einstein Cancer Clinical Trials Office.
• 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).
• Provide routine reviews and determine if there are compliance concerns that warrant a formal investigation of the trials.
• Execute duties 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.
• Work under the direction of the Director, Quality Assurance and provide feedback on findings and evaluation of instituted Corrective and Preventative Action Plans (CAPA).
• Administer the MECC Data and Safety Monitoring Committee.
• 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