Clinical Research Monitoring and Auditing Specialist (Abramson Cancer Center)

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Posted Job Title

Clinical Research Monitoring and Auditing Specialist (Abramson Cancer Center)

Job Profile Title

Clinical Research Quality Specialist C

Job Description Summary

The Abramson Cancer Center (ACC) Department of Operations, Compliance and Monitoring (DOCM) is seeking a The Clinical Research Quality Specialist, Sr. to support our clinical research mission. The ACC clinical research portfolio comprises hundreds of studies with many being conduct across the US and in other countries. The Quality Specialist, Sr. is responsible for scheduling, coordinating and conducting monitoring and/or auditing of oncology studies across the Abramson Cancer Center which includes 12 schools, HUP, PPMC, PAH, CCG, ABBCI@LGH, PMPH, CHOP, all ACC network and affiliates as well external sites participating in ACC initiated clinical research.

NOTE: Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week divided between working onsite multiple days a week in Philadelphia and working locally off-site. Applicants must live within a reasonable commute to downtown Philadelphia.

Visa support is not available for this position.

Job Description

Job Responsibilities

• Perform monitoring and auditing visits of all ACC studies as assigned.
• Conduct visit close-out meetings with study teams and investigators.
• Prepare formal reports of audit findings following NCI/CTEP quality and compliance standards.
• Assist with the development and implementation of corrective and preventative action plans and training related to research compliance, quality control and quality assurance to ensure compliance with federal regulations and NIH and NCI mandates.
• Play a vital role in performing quality reviews of pharmacovigilance data that are evaluated and acted on by the ACC Data and Safety Monitoring Committee.
• Strictly adhere to all ACC DOCM policies and procedures as well as have a thorough understanding of federal and loc