• Assists and participates in contracted audits (investigator sites, trial master files, databased, study reports etc.) and internal audits (systems, processes, vendors, computer system validation etc.) across global operations, (including preparation of audit plans, audit checklists, audit reports and certificates

• Helps project manage compliance issues, running investigations with operational teams

• Assists the maintenance of the Global Quality Management System

• Supports Premier Research in ensuring the effectiveness of the Quality Management System and the quality of the deliverables

• Assist in the conduct detailed QA review of SOPs prior to approval

• Drives input into process improvement initiatives across the company

What we are searching for:

• Bachelor’s degree, or international equivalent from an accredited institution, in Health or Life Sciences, or equivalent experience

• At least 5 years specialized GCP and ISO experience in auditing clinical trials including auditing internal processes and performing vendor audits

• Ability to interpret research protocols and audit medical records

• Experience in hosting and responding to regulatory inspections preferred

• Experience with paper-based data management systems; experience with RDC/EDC data

• Preferred Location: East Coast

• Please note this is a 12 month 1099 contractor opportunity

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.