Clinical Trial Research Monitor II

Temple University Health System operates Fox Chase Cancer Center and supports clinical research programs. The Clinical Trial Research Monitor II reviews and maintains documentation and processes for FDA and regulatory compliance, monitors investigator-initiated studies, and ensures protocol compliance at clinical research sites.

Responsibilities

• The OCR Clinical Research Monitor II, completes, revises and reviews the requirements necessary to attaining and maintaining compliance with the FDA and other regulatory bodies for clinical trial research both from a documentation and process level
• Monitors all extramural research program investigator initiated studies being conducted at FCCC and other academic institutions
• Ensures protocol compliance at the clinical research sites

Preferred

• Master's Degree Clinical Research or other applicable science or healthcare discipline Preferred
• 3 years experience in oncology clinical research Preferred
• Master's Degree
• Oncology Clinical Research

Company

• Philadelphia-based academic health system for advanced patient care
• Philadelphia, Pennsylvania, USA
• https://www.templehealth.org/
• Founded in 1892
• 10001+ employees

Qualifications

• Bachelor's Degree Science or other health care discipline Required
• Combination of relevant education and experience may be considered in lieu of degree Required
• 2 years experience in oncology Required
• 2 years experience working as a Clinical Research Monitor Required
• Cert Clin Research Associate Required or
• Cert Clin Research Coordinator Required
• Cert Clin Research Prof Required
• This role is located in Philadelphia, PA and no traveling is required
• Master's Degree Clinical Research or other applicable science or healthcare discipline Preferred
• 3 years experience in oncology clinical research Preferred

Required skills

• Clinical Research Associate Certification, Clinical Research Coordinator Certification, Clinical Research Monitoring, Clinical Research Professional Certification, Clinical Trial Documentation, FDA Regulatory Compliance, Oncology Clinical Research, Protocol Compliance

Preferred skills

• (1), (2), (4), (6), *2026, 2020, 2021, 2022, 2023, 2024, 2025, 3 years experience in oncology clinical research Preferred, 3.5, 95, At Temple Health, more is how excellence is defined., Chief Financial Officer, Claire Raab MD, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, Engineering and Development, Gerald P. Oetzel, Glassdoor, H1B Sponsorship, Late Stage, Leadership Team, Management and Executive, Philadelphia, Pennsylvania, USA, Represents job field similar to this job, Trends of Total Sponsorships, https://www.templehealth.org/

Experience

• 2+ years