Program Manager Clinical Research (JR227773)

ViziRecruiter,LLC.; New York (NY); On-site; USD 85,000 - 115,000; Full time

Job summary

A healthcare organization is seeking a Clinical Research Program Manager to oversee quality assurance for clinical trials. The candidate will ensure compliance with regulatory standards and manage ongoing monitoring activities. Required qualifications include a Bachelor's degree, 5 years of experience, and strong project management skills. This role demands leadership and the ability to work independently. Competitive compensation and benefits offered.

Qualifications

• 5 years of work experience required.
• Minimum of 3 years of experience in clinical research.
• CCRP/CCRC Certification preferred.

Responsibilities

• Provide compliance and quality assurance reviews.
• Conduct routine reviews of clinical trials.
• Develop eligibility review processes for clinical studies.

Skills

Critical thinking

Project management

Communication

Leadership

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

The Clinical Research Program Manager - Monitor, 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).

Responsibilities

• 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 - Monitor 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).
• The Clinical Research Program Manager - Monitor will serve as the Administrator for the MECC Data and Safety Monitoring Committee.
• In addition, the Clinical Research Program Manager - Monitor will 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.