Clinical Research Quality & Compliance Manager

3000 Montefiore Medical Center; United States; On-site; USD 84,000 - 105,000; Full time

Job summary

Montefiore Medical Center in Bronx, NY seeks a Clinical Research Program Manager, Monitor, to perform compliance and QA reviews for the Cancer Clinical Trials Office under the Director of Quality Assurance. The role oversees monitoring activities, patient reviews, and regulatory assessments for investigator-initiated trials.

The ideal candidate has a Bachelor’s degree (master’s preferred), 5 years of work experience, and at least 3 years in clinical research, with CCRP/CCRC preferred and FDA

Qualifications

• Bachelor's degree required; master's preferred.
• Minimum 5 years of work experience.
• Minimum 3 years in clinical research.
• CCRP/CCRC certification preferred.
• Experience with internal audits or FDA inspection prep.
• Knowledge of FDA, OHRP, GCP and related regulatory standards.

Responsibilities

• Provide compliance and quality assurance reviews for Montefiore Einstein Cancer Clinical Trials Office.
• Monitor patient case reviews, pharmacy reviews, and regulatory reviews for investigator-initiated trials.
• Develop and support eligibility review processes for patients enrolled in cancer clinical studies.

Skills

Quality assurance

Regulatory knowledge

CAPA

Project management

FDA inspections

Education

Bachelor's degree

Master's degree preferred

Job description

Montefiore Medical Center in Bronx, NY seeks a Clinical Research Program Manager, Monitor, to perform compliance and QA reviews for the Cancer Clinical Trials Office under the Director of Quality Assurance. The role oversees monitoring activities, patient reviews, and regulatory assessments for investigator-initiated trials.

The ideal candidate has a Bachelor’s degree (master’s preferred), 5 years of work experience, and at least 3 years in clinical research, with CCRP/CCRC preferred and FDA