Research Quality Analyst

Job Description

The Research Quality Analyst works under the supervision of Quality Assurance Manager to ensure compliance to all processes contributing to the performance of a clinical trial within the Clinical TrialsOffice(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

• 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

Minimum Required Education

Bachelor's degree in scientific discipline, or an equivalent combination of training and experience.

Required Qualifications

1 year of experience in clinical research and/or healthcare-related field. Clinical research certification from an accredited certifying agency desired. Computer skills required with experience using Microsoft Software applications desired. Previous quality assurance experience with clinical trials preferred.