Clinical Quality Assurance Consultant

Job Summary
We are looking for an Consultant with GCP Quality Assurance experience to help with a variety of activities for pre-commercial programs. This individual will be responsible for providing expertise and guidance on Good Clinical Practice (GCP), applicable regulations to clinical and nonclinical development teams. They will work with internal clinical functions and external parties to develop an audit and compliance strategy for all programs.

Responsibilities:

• MUST HAVE WORKED in CLINICAL QA- not just clinical operations
• Provide expertise in GCP, compliance interpretation, consultation, training, and recommendations to clinical development functions and program teams
• Lead investigations into significant quality issues, scientific misconduct and suspected serious breach of GCP or GLP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate
• Manage deviations and CAPAs through completion
• Appropriately escalate any quality/compliance issues to relevant leadership
• Perform a quality assurance review of documents and data intended for regulatory submission
• Perform quality assurance and GCP compliance review of various clinical study documentation such as study protocols, ICFs, monitoring plans, clinical study reports, etc.
• Create, revise and review of GCP systems related SOPs to assess their adherence to applicable regulatory standards and corporate goals. Create and give training as needed
• Perform Audits as required

Requirements:

• 8 years of clinical trial experience in a pharmaceutical, biotech, hospital setting, or a CRO is required with at least 5 years managing clinical trials.
• 5 years working in Clinical Quality
• Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development Advanced knowledge in the management of quality events and GCP deviations, inclusive of conducting robust root cause analysis and developing CAPA plans that mitigate risks to the company, to safety and data integrity
• Internal and External Auditing experience

Job Types: Full-time, Contract, Temporary

Pay: $80.00 - $110.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Professional development assistance
• Referral program
• Relocation assistance
• Vision insurance

Schedule:

• Monday to Friday

Work Location: In person

Salary : $80 - $110