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Clinical Research Integrity Coordinator at Temple University Health System

Philadelphia, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Oct, 26

Salary

0.0

Posted On

09 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Auditing, Regulatory Compliance, ICH-GCP Guidelines, Medical Chart Review, Eligibility Verification, Quality Assurance, Pharmaceutical Audit Preparation, Clinical Research Coordination, Data Accuracy Verification, Patient Safety Protection

Industry

Hospitals and Health Care

Description

The Research Quality Assurance Analyst reviews the requirements necessary for attaining and maintaining compliance with the FDA and other regulatory bodies for clinical trial research both from a documentation and process level. Promotes adherence to ICH-GCP guidelines by ensuring that data reported is accurate and complete and guarantees that the rights and safety of participants in clinical research are protected. This is accomplished by serving as a resource for the entire Office of Clinical Research (OCR) staff. Assists with pharmaceutical audit preparations and audit responses. Performs eligibility verifications and chart reviews. Research QA Analysts are an integral part of the infrastructure development and help to coordinate projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial education efforts Education Bachelor's Degree Required Other Graduate of an accredited school of nursing Preferred or Combination of relevant education and experience may be considered in lieu of degree Required Experience 1 year experience in a health care environment as a Clinical Research Associate, Clinical Research Coordinator Clinical research Nurse or Medical Chart Auditor Required 2 years experience in clinical trials auditing Preferred 2 years experience in oncology Preferred Licenses Cert Clin Research Coordinator Preferred or Cert Clin Research Associate Preferred Cert Clin Research Prof Preferred Assn Clin Res Prof - Cert Prof Preferred PA Registered Nurse License Preferred PA Practical Nurse License Preferred Multi State Compact RN License Preferred Or

Responsibilities

The coordinator ensures clinical trial compliance with FDA and regulatory bodies by reviewing documentation and processes. They serve as a resource for the Office of Clinical Research, assisting with audits and implementing quality management initiatives.