You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What you'll be doing:
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.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
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What We Do
We’re out to change the course of medical science. Are you ready to rise to the challenge? Premier Research is not about being everything to everyone. Instead, our deep, focused expertise targets the therapeutic areas and indications where today’s biotech and specialty pharma pioneers are doing the most amazing work. We’re 1,500 employees strong and operate in more than 20 countries, delivering unmatched expertise, operational skills, and dedication to meeting customers’ most challenging needs. Join us and meet some of the brightest minds in clinical development today — people who apply their best thinking to every project, recognizing that what they do significantly affects the lives and well-being of customers, patients, physicians, and colleagues. You’ll enjoy great benefits and very flexible working conditions in a company that values your contributions, rewards your achievements, and is committed to helping you reach your full potential. Are you ready to make a real difference and help us transform this exciting industry? Follow our company page for more information about us and the work we do, and check out our current openings for your next career move!
