- Manage assigned R&D Quality Risk Management activities – assessment of QC of clinical trials execution in a GCP regulated environment
- Support Drug Safety Pharmacovigilance, Computer System Validation and GLP
- Work closely with internal R&D teams and Contract Service Providers as clinical trials are designed and conducted
- Identify issues and compliance risks, measure performance metrics, and suggest areas for improvement for clinical trial related processes and procedures
- Lead or support implementation of suggested improvements
- Bachelors or Master's degree in scientific field
- 6+ years R&D focused pharmaceutical experience in a GCP regulated environment
- Experience in R&D Quality Risk Management or R&D QA systems and Health Authority regulations
- Experience with drug development process – clinical protocol development, global trial management and monitoring, drug safety, biostatistics and programming and/or data management
- Strong GCP knowledge
- Schedule: Monday-Friday
- Hybrid – must be ok to come onsite 3 days a week (preferably Tuesday / Wednesday)
- Position type: 1-year contract
- Pay rate range approved $55-63/hr depending on experience
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Clinical Quality and Compliance Specialist - Princeton, United States - Russell Tobin
Description
The Scientific Team at Russell Tobin & Associates is supporting an exciting pharmaceutical organization that has an opening for a Clinical Quality & Compliance Specialist near Princeton, NJ
Responsibilities
Requirements:
Additional Details:
Must be authorized to work in the United States.
Russell Tobin offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.
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About Us
Russell Tobin is a leading minority-owned professional and technical recruitment and staffing advisory organization.
We are comprised of specialized practices focusing on a variety of skill sets and industries. Having a depth and breadth of industry expertise, our subject matter experts are able to provide tailored and swift sourcing solutions to fulfill client hiring needs. In other words, we connect top talent with companies.
We are the staffing arm of the Pride Global network, a minority-owned integrated human capital solutions firm, with additional offerings in vendor management, payroll programs, and business process optimization.
As a certified minority-owned business, Pride Global and its affiliates - including Russell Tobin, Pride Health, and Pride Now - are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.
