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Clinical Research Monitor II at Temple University Health System

Philadelphia, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Oct, 26

Salary

0.0

Posted On

06 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Monitoring, FDA Compliance, Regulatory Affairs, Protocol Compliance, Oncology Research, Clinical Documentation, Site Monitoring

Industry

Hospitals and Health Care

Description

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. Other applicable certification, related training, or education programs may be considered in lieu of those listed below (i.e. Regulatory Affairs). Education Bachelor's Degree Science or other health care discipline Required Master's Degree Clinical Research or other applicable science or healthcare discipline Preferred or Combination of relevant education and experience may be considered in lieu of degree Required Experience 2 years experience in oncology Required 2 years experience working as a Clinical Research Monitor Required 3 years experience in oncology clinical research Preferred Licenses Cert Clin Research Associate Required or Cert Clin Research Coordinator Required Cert Clin Research Prof Required

Responsibilities

The role involves monitoring extramural research program investigator-initiated studies to ensure protocol compliance. It also requires maintaining documentation and processes to meet FDA and other regulatory body requirements.