Clinical Quality Assurance Consultant Job at Redbock- an NES Fircroft company
Redbock- an NES Fircroft company Remote
A specialized Pharmaceutical company is expanding its operations to San Diego and needs to build its teams quickly. The team is in immediate need of a Clinical QA Consultant to support them for at least 6 months (client is evaluating contract-hire as an option). This consultant can work remotely, but he or she may need to travel to the San Diego offices once/month. All travel expenses will be reimbursed or covered by the client.
This position will be focused on the direct oversight of clinical studies as well as hands-on development of SOPs. This position is not purely an auditor role. The consultant will serve as a CQA lead representative on the clinical team assuring quality and regulatory compliance related to GCPs, pharmacovigilance, and other related activities performed by Medical/Clinical Departments.
Duties:
- Establish and maintain a risk-based and scientific-based quality system to support GCP
- Oversee GCP activities, including internal or external audit observations and development of adverse trends, to ensure patient safety and data integrity
- Manage quality documentation in Veeva QMS and Vault
Top Requirements:
- 5+ years of experience as a Clinical QA specialist supporting pharma and/or biotech companies
- BS degree minimum
- Experience managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections
- Experience developing SOPs, reviewing internal clinical, regulatory and medical processes
- Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice
- Experience with Phases I-IV (particularly Phase III); experience with Regulatory approval, NDAs / BLAs and MAAs
Job Types: Full-time, Contract
Pay: $70.00 - $110.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Experience:
- GCP: 5 years (Required)
- Phases I-IV clinical trial: 3 years (Required)
- NDAs/BLAs and MAAs: 3 years (Required)
Work Location: Remote
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