Clinical Research Monitoring & QA Manager

Montefiore; 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

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