PURPOSE

Personnel are an important part of a tumor biobank. Descriptions of roles and responsibilities are important for selecting, hiring, and supervising qualified individuals. Tumor biobank personnel are encouraged to participate in the biobanking process in accordance with their professional roles and responsibilities.

SCOPE

This standard operating procedure (SOP) outlines a process that should be followed to ensure that all employees have clear definition of their role and responsibility within the tumor biobank.

REFERENCE TO OTHER TJUHBB SOPS OR POLICIES

Note: All TJUHBB SOPs define roles and responsibilities.

ROLES AND RESPONSIBILITIES

Although the head of the tumor biobank is responsible for overseeing the tumor biobank program, all personnel have defined roles and responsibilities and should be familiar with this SOP. Note that roles at some biobanks may overlap. The roles and responsibilities should be used as a guide to ensure that personnel are qualified by education and training to accomplish their respective jobs.

MATERIALS, EQUIPMENT AND FORMS

The materials, equipment and forms listed in the following list are recommendations only and may be substituted by alternative/equivalent products more suitable for the site-specific task or procedure.

Materials & Equipment	Site Specific Materials
Institutional Job Descriptions
Job Description Form
Organizational Chart	Through JeffPortal

DEFINITIONS

See the TJUHBB Glossary.

PROCEDURES

Job descriptions aid in the construction of organizational charts that may be referred to by Management when allocating resources or personnel for operation of the tumor biobank. They may also be used to ensure that tumor biobank personnel are appropriately qualified to perform his or her assigned task.

Procedure for Creating Job Descriptions

A comprehensive and detailed job description should be developed for each position.
Position Title, Department, and Location: Provide the title, the department and the location of the position.
Primary purpose of role: Describe the primary purpose of the position in one or two brief sentences.
Essential functions: Most personnel perform a variety of duties. Describe the major, or most important functions and responsibilities of the position.
Tumor Biobank Responsibilities: Include all responsibilities that may be relevant for the position.
Qualification: Enter minimum education and/or certification required for the position.
Basic Competencies and minimum experience: Enter basic competencies and minimum work experience required.
Special Skills: List special skills required.

List of Roles and Responsibilities

ROLE: Information Technology Staff

Conducts routine backup of database according to specific biobank plan.
Monitors Access to Informatics System.
Oversees data transmission – Schedules data export, monitors submission status, reviews process logs for errors and makes corrections when needed.
Monitors and implements security policy adopted by the biobank.
Uses best practices for computer hardware and software security.
Prepares and sends data records for external use.

ROLE: Clinical Research Coordinator/Nurse

Communicates with patients if consent is withdrawn.
Public relations with clinical community. Interfaces with partners in clinical community.

ROLE: Tumor Biobank Coordinator/Manager

Obtains and documents consent
Communicates with patients to inform them about the tumor biobank program
Creates and maintains filing system for storing confidential records and retrieves records when needed.
Enters clinical and pathology data into database.
Enters inventory information into the database.
Contributes to the development and maintenance of SOPs.
Assesses quality of tissues and derivatives.
Labels and tracks samples.
Harvests tissue.
Processes tissue in pathology laboratory.
Processes Tissue in derivatives such as DNA, RNA and protein.
Processes and separates blood into components and derivatives.
Records and documents laboratory processes.
Collects pathology reports about each case
Investigates, reports and documents deviations in practice.
Coordinates quality assessment of samples.
Coordinates privacy and security is maintained in tumor biobank.
Coordinates training of tumor biobank personnel.
Coordinates operations and Quality Assurance at Tumor Biobank.

ROLE: Histology Technician/technologist

Fixes tissue.
Embeds tissue in paraffin
Cuts tissue sections.
Stains sections.
Prepares Tissue Microarrays.

ROLE: Operating Room Nurse

Communicates to Tumor biobank nurse that suitable sample may be available for biobanking.

ROLE: Tumor Biobank Director/Head

Oversees hiring of tumor biobank personnel.
Oversees education and training of tumor biobank personnel.
Responsible for approving SOPs.
Oversees material release.
Responsible for Operations at Tumor Biobank.

APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES

Handbook for Good Clinical Research Practice.
http://whqlibdoc.who.int/publications/2005/924159392X_eng.pdf
Responsibilities of Tumor Bank Personnel. OCRN SOP AD102.001 Draft version 3.
Job Descriptions and Organizational Chart. SOP HRS.001.00 British Columbia Tumour Tissue Repository.
Job Summaries, NCIC Clinical Trials Group, Kingston, Ontario.