Clinical Research QA & Compliance Program Manager

Montefiore Mount Vernon; New York (NY); Vor Ort; USD 84.000 - 105.000; Vollzeit

Zusammenfassung

Montefiore Medical Center is seeking a Clinical Research Program Manager to provide compliance and QA reviews for the Cancer Clinical Trials Office. The role oversees monitoring activities (patient cases, pharmacy, regulatory reviews) to ensure adherence to GCP and DSMP, with CAPA and committee administration responsibilities.

The candidate will work under the Director of Quality Assurance, ensuring FDA and OHRP regulatory alignment and efficient, compliant trial operations across

Qualifikationen

• Bachelor’s degree required; master’s degree preferred.
• Minimum of 3 years of experience in clinical research.
• 5 years of work experience required.
• CCRP/CCRC Certification preferred.
• Prior experience with internal audits and/or FDA inspection preparations.
• Knowledge of federal (FDA, OHRP, GCP) and other regulatory standards for clinical research.
• Strong knowledge of ongoing monitoring techniques and CAPA.
• Ability to manage multiple projects and meet deadlines.
• Excellent written and verbal communication.

Aufgaben

• Provide compliance and quality assurance reviews for Montefiore Einstein Cancer Clinical Trials Office.
• Perform ongoing monitoring: patient case reviews, pharmacy reviews, regulatory reviews.
• Determine if compliance concerns warrant formal action.
• Serve as Administrator for MECC Data and Safety Monitoring Committee.
• Develop and support eligibility review processes for patients enrolled on cancer studies.

Kenntnisse

Quality assurance

Regulatory knowledge

Clinical research

Project management

CAPA

FDA inspections

GCP/SOPs

Data and safety monitoring

Ausbildung

Bachelor’s degree

Master’s degree

CCRP/CCRC Certification

Jobbeschreibung

Montefiore Medical Center is seeking a Clinical Research Program Manager to provide compliance and QA reviews for the Cancer Clinical Trials Office. The role oversees monitoring activities (patient cases, pharmacy, regulatory reviews) to ensure adherence to GCP and DSMP, with CAPA and committee administration responsibilities.

The candidate will work under the Director of Quality Assurance, ensuring FDA and OHRP regulatory alignment and efficient, compliant trial operations across