Program Manager Clinical Research (JR230073)

ViziRecruiter,LLC.; New York (NY); On-site; USD 120,000 - 170,000; Full time

Job summary

Montefiore Einstein Cancer Center seeks a Clinical Research Program Manager to provide compliance and quality assurance reviews for the Cancer Clinical Trials Office. The CRM will monitor patient case reviews, pharmacy reviews and regulatory activities in accordance with GCP and DSMP guidelines.

Reporting to the Director of Quality Assurance, this role administers the MECC Data and Safety Monitoring Committee and helps develop eligibility reviews for cancer study participants, ensuring trials

Qualifications

• Bachelor's degree required; Master's degree preferred.
• 5 years of work experience required.
• Minimum of 3 years in clinical research.
• CCRP/CCRC Certification preferred.
• Experience with internal audits and FDA inspection preparations.
• Strong knowledge of FDA, OHRP, GCP and other regulatory standards.
• Knowledge of ongoing monitoring techniques and CAPA.
• Project management and ability to handle multiple projects.
• Strong communication and leadership skills.
• Ability to work with minimal supervision.

Responsibilities

• Provide QA reviews for cancer clinical trials under supervision of the Director, Quality Assurance.
• Serve as the Administrator for the MECC Data and Safety Monitoring Committee.
• Develop and support an eligibility review process for patients enrolled in cancer studies.

Skills

Regulatory knowledge

GCP

CAPA management

Project management

Communication

Leadership

Quality assurance

Audits

FDA inspections

Education

Bachelor's degree

Master's degree

Job description

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

TheClinical ResearchProgramManager,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 ResearchProgramManager- 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

• 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 in 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.