Clinical Research Technician

2 weeks ago

Chapel Hill, North Carolina, United States InsideHigherEd Full time
Department:

Lineberger Comprehensive Cancer Center

Career Area:

Research Professionals

Position Type:

Permanent Staff (EHRA NF)

Working Title:

Research Associate

Appointment Type:

EHRA Non-Faculty

Full Time/Part Time:

Full-Time Permanent

Hours per week:

40

Hiring Range:

Dependent on Education/Experience

Position Summary:

The role of Quality Control Testing is essential in the manufacturing process to support the production of treatments for patients. The individual in this position will oversee the evaluation of human cellular therapy products intended for administration to patients participating in clinical trials, adhering to all regulatory standards to ensure compliance with federal and state regulations. The cell products may originate from patients with infectious diseases, including HIV.

This position entails:

  • Interpreting scheduled manufacturing processes and preparing necessary testing.
  • Completing testing within the required timeframe to ensure timely reporting of results and batch release for patient treatment.
  • Developing essential methodologies, such as new templates for flow analysis, in support of new clinical protocols.
  • Assessing results and identifying any deviations from specifications or trends.
  • Documenting findings accurately, reporting to management, and conducting investigative testing in accordance with regulatory requirements.
  • Managing inventory and reagents to ensure availability and prevent any impact on patient treatments.
  • Overseeing stability testing, creating stability plans, managing testing schedules, and generating reports.
  • Evaluating testing results to confirm trends and identifying any outliers, creating management reports on data trends to validate robust testing practices.
  • Developing Standard Operating Procedures (SOPs) and collaborating with investigators to translate bench-scale techniques into large-scale production.
Minimum Education and Experience Requirements:

A relevant post-Baccalaureate degree is required (or foreign degree equivalent); candidates demonstrating comparable independent research productivity may substitute a relevant Bachelor's degree (or foreign degree equivalent) along with three or more years of relevant experience. A terminal degree and licensure may be required.

Required Qualifications, Competencies, and Experience:

Proficiency and experience in Quality Control testing methodologies, including Endotoxin, Mycoplasma by PCR, and Flow Cytometry. Experience in technical writing and the development of SOPs and reports is essential. Familiarity with following and utilizing SOPs to execute activities is required.

Preferred Qualifications, Competencies, and Experience:

Knowledge in biological or chemical sciences and experience in a Good Manufacturing Practice (GMP) environment are preferred.

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