Clinical Trials Laboratory Specialist
1 week ago
The Clinical Trials Laboratory Specialist plays a pivotal role in executing specialized laboratory tasks for clinical research, utilizing advanced laboratory techniques. This includes, but is not limited to, the routine extraction of peripheral blood mononuclear cells (PBMC), conducting flow cytometry, and isolating DNA/RNA, while adhering to stringent safety protocols to ensure efficient laboratory operations.
Key Responsibilities
- Prepare, process, and dispatch laboratory specimens to external facilities in compliance with IATA regulations.
- Execute PBMC sample processing and preservation techniques.
- Authenticate subjects by verifying identification details.
- Ensure specimen integrity through aseptic techniques and adherence to established protocols.
- Maintain accurate records of collected specimens, including initialing, dating, and documenting collection times.
- Foster a safe and healthy work environment by following regulatory standards and procedures.
- Enhance professional knowledge by engaging in educational opportunities and staying updated with industry publications.
- Contribute to the laboratory's success by taking initiative on new requests and identifying ways to improve job performance.
- Monitor and manage inventory levels of laboratory supplies and kits, placing orders as necessary.
- Provide training and support to fellow laboratory technicians as needed.
- Organize laboratory space and streamline operational workflows.
- Conduct clinical studies in accordance with FDA regulations and guidelines.
- Safeguard the safety and welfare of study participants by ensuring compliance with ICH/GCP and organizational Standard Operating Procedures.
- Possess a thorough understanding of the sponsor's protocol to ensure accurate completion of study activities.
- Perform additional tasks as assigned by management.
Qualifications
Education:
- Bachelor's degree is mandatory.
- Fundamental laboratory management experience.
- 1-2 years of experience in PBMC techniques.
- Phlebotomy certification is preferred.
- Exceptional attention to detail and adherence to deadlines.
- Familiarity with scientific methods, procedures, and techniques.
- Strong written and verbal communication skills are essential.
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