JOB SUMMARY

The majority of the Biorepository operations will be performed by Biorepository Specialists. Biorepository Specialists will perform a combination of common, general, and specialized functions. There are responsibilities for all Biorepository Specialists (common functions) that will include:

• The proper performance of all Biorepository Policies and Procedures relative to their job position and duties.
• Compliance with the Biorepository Quality Management program and quality improvement programs.
• Compliance with the BSWRI and Biorepository safety programs.

General functions are those that are typically required from day-to-day operations such as specimen processing, accessioning, storage, distribution, general laboratory maintenance, quality control/quality assurance and safety functions.
Specialty functions refer to functions that are required, but are not necessarily shared by all Biorepository Specialists. Specialty functions include: Supervisory roles, Freezerworks specialization, tissue collection, functions as Biorepository Safety Officer and Biorepository Quality Officer.

ESSENTIAL FUNCTIONS OF THE ROLE

• Assists with development of Policies and Procedures
• May assist in specialized biorepository operations (e.g., phlebotomy)
• May have specialty training as a Clinical Research Associate (CRA). Professional certification optional, but appreciated.
• Will assist in development and maintenance of IRB approval in the role of regulatory specialist.
• May obtain patient consent
• Manages the healthy donor program.
• May manage individual research projects if delegated by the official “workflow” for that project, regulatory binders, delegation logs etc.
• Phlebotomy (optional)
• Keeps minutes of weekly scheduled Biorepository Operations meeting.
• Assists in creation and curates project-specific “Workflow” documents.
• Reagent materials management. Maintains supplies/equipment inventory.
• Manages Proficiency Testing program.
• Communicates with IRB and submits IRB documentation as needed (i.e., continuing review, KSP)
• Any other tasks as assigned by management

The majority of the Biorepository operations will be performed by Biorepository Specialists. Biorepository Specialists will perform a combination of common, general, and specialized functions. There are responsibilities for all Biorepository Specialists (common functions) that will include:

• The proper performance of all Biorepository Policies and Procedures relative to their job position and duties.
• Compliance with the Biorepository Quality Management program and quality improvement programs.
• Compliance with the BSWRI and Biorepository safety programs