Senior Research Quality Analyst

Job Description

The Senior Research Quality Analyst serves as a lead resource to ensure compliance to all processes contributing to the performance of a clinical trial within the Clinical Trials Office (CTO).

Responsibilities

• Performs detailed internal quality checks on essential regulatory files and patients enrolled on a clinical trial applying professional research experience to assess research participant safety, data integrity and research compliance with applicable institutional standard operating procedures (SOPs), Good Clinical Practices (GCP) and all applicable regulations

• Recommends necessary steps to resolve any identified compliance issues identified on internal quality checks

• Manages corrective and preventative action plans in response to internal/external audits, FDA Inspection or sponsor monitoring visits

• Serves as a resource for less experienced colleagues and provides guidance and support to all members of the research team

• Develops new quality improvement processes to ensure on-going compliance to quality standards for the conduct of all clinical trials with the CTO

• Develops and presents reports to operations managers and CTO directors

• Coordinates and assists with preparations for external audits by IRB, federal or industry sponsors

• Works in conjunction with the CTO Training Team and CTO Internal Monitoring Team as needed

• Participates in writing and implementing Standard Operating Procedures (SOPs) for the CTO

• Maintains detailed knowledge of applicable University State Federal International regulations and Good Clinical Practice (GCP) guidelines pertaining to research in human subjects

• Serves as the subject matter expert for all research quality analysts within the CTO

• Reviews quality reports and answers questions of junior members on the team

• Provides coverage/back up as needed for Quality Assurance manager and/or team members

• Works with CTO Managers and coordinators as needed to ensure understanding of CTO policies and procedures

Minimum Education Required

Bachelors Degree in biological sciences, health sciences, social sciences or other medical field, or an equivalent combination of education and experience required. Masters degree in a relevant field desired.

Three to five years experience in a progressively responsible clinical research or administrative capacity working in clinical research required. Clinical research certification from an accredited certifying agency required. Computer skills required with experience using Microsoft Software applications desired.