CTRNet Standard Operating Procedure Job Descriptions, Roles and Responsibilities
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1 CTRNet Standard Operating Procedure SOP Number: Version: e2.0 Supersedes: e1.0 Category: Administration 1.0 PURPOSE Approved By: CTRNet Management Group Per: Brent Schacter 01-May May-2012 Personnel are an important part of a tumour biobank. Descriptions of roles and responsibilities are important for selecting, hiring, and supervising qualified individuals. Tumour biobank personnel are encouraged to participate in the biobanking process in accordance with their professional roles and responsibilities. 2.0 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 tumour biobank. 3.0 REFERENCE TO OTHER CTRNET SOPS OR POLICIES Note: When adopting this SOP for local use please reference CTRNet. Note: All CTRNet SOPs define roles and responsibilities. 4.0 ROLES AND RESPONSIBILITIES Although the head of the tumor biobank is responsible for overseeing the tumour 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. Tumour Biobank Personnel Responsibility/Role Pathology Assistant See Procedures (section 7) Bioinformatics Specialist See Procedures (section 7) Clinical Research Coordinator/Nurse See Procedures (section 7) Data Entry Clerk See Procedures (section 7) Histology Technician/technologist See Procedures (section 7) Laboratory Technician/technologist See Procedures (section 7) Operating Room Nurse See Procedures (section 7) Pathology Coordinator/Assistant See Procedures (section 7) Physicians involved with the Tumour Biobank Program (Oncologist, Surgeon, See Procedures (section 7) Copyright 2012 Canadian Tumour Repository Network (CTRNet). Page 1 of 7
2 Pathologist) Porter See Procedures (section 7) Tumour Biobank Coordinator/Manager See Procedures (section 7) Tumour Biobank Director See Procedures (section 7) e MATERIALS, EQUIPMENT AND FORM 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 and Equipment Materials and Equipment (Site Specific) Institutional Job Descriptions Job Description Form Organizational Chart if available 6.0 DEFINITIONS See the CTRNet Program 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 tumour biobank. They may also be used to ensure that tumour biobank personnel are appropriately qualified to perform his or her assigned task. 7.1 Procedure for Creating Job Descriptions A comprehensive and detailed job description should be developed for each position. See form in Appendix A for Job Descriptions 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 Tumour 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. Copyright 2012 Canadian Tumour Repository Network (CTRNet). Page 2 of 7
3 7.2 List of Roles and Responsibilities ROLE: Information Technology Staff a. Conducts routine backup of database according to specific biobank plan. b. Monitors Access to Informatics System. c. Oversees data transmission Schedules data export, monitors submission status, reviews process logs for errors and makes corrections when needed. d. Monitors and implements security policy adopted by the biobank. e. Uses best practices for computer hardware and software security. f. Prepares and sends data records for external use ROLE: Clinical Research Coordinator/Nurse a. Obtains and Documents Consent. b. Communicates with patients to inform them about the tumour biobank program. c. Communicates with patients if consent is withdrawn. d. Draws blood. e. Public relations with clinical community. Interfaces with partners in clinical community ROLE: Data Entry Clerk a. Creates and maintains filing system for storing confidential records. b. Retrieves records when needed. c. Enter clinical and pathology data into database. d. Enter consent information. e. Enter inventory information if appropriate ROLE: Histology Technician/technologist a. Fixes tissue. b. Embeds tissue in paraffin or Optimal Cutting Temperature Compound (OCT). c. Cuts tissue sections. d. Stains sections. Copyright 2012 Canadian Tumour Repository Network (CTRNet). Page 3 of 7
4 7.2.5 ROLE: Laboratory Technician/technologist a. Fixes tissue. b. Embeds tissue in paraffin or Optimal Cutting Temperature Compound (OCT). c. Cuts tissue sections. d. Prepares Tissue Microarrays. e. Freezes tissues and derivatives. f. Processes Tissue in derivatives such as DNA, RNA and protein. g. Processes and separates blood into components and derivatives. h. Assesses quality of tissues and derivatives. i. Contributes to development of technical SOPs. j. Labels and tracks samples. k. Records and documents laboratory processes. l. Enters inventory information into the database. m. Retrieves and ships samples according to procedure ROLE: Operating Room Nurse a. Communicates to Tumour biobank nurse that suitable sample may be available for biobanking ROLE: Pathology Coordinator/Assistant a. Primary lead on specimen collection. b. Harvests tissue. c. Processes tissue in pathology laboratory. d. Communicates to tumour biobank personnel that tissue is available for biobanking. e. Performs tasks assigned by the pathologist. f. Collects pathology reports about each case ROLE: Tumour Biobank Coordinator/Manager a. Contributes to the development of SOPs. b. Maintains SOPs for the biobank. c. Coordinates material requests and release. d. Coordinates development and maintenance of Informatics System. e. Investigates, reports and documents deviations in practice. Copyright 2012 Canadian Tumour Repository Network (CTRNet). Page 4 of 7
5 f. Coordinates quality assessment of samples. g. Coordinates privacy and security is maintained in tumour biobank. h. Coordinates training of tumour biobank personnel. i. Coordinates Inventory verification. j. Coordinates operations and Quality Assurance at Tumour Biobank. k. Selects samples for shipment ROLE: Tumour Biobank Director/Head a. Oversees hiring of tumour biobank personnel. b. Oversees education and training of tumour biobank personnel. c. Responsible for approving SOPs. d. Oversees material release. e. Responsible for Operations at Tumour Biobank. 8.0 APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES 8.1 Handbook for Good Clinical Research Practice Responsibilities of Tumour Bank Personnel. OCRN SOP AD Draft version Job Descriptions and Organizational Chart. SOP HRS British Columbia Tumour Tissue Repository. 8.4 Job Summaries, NCIC Clinical Trials Group, Kingston, Ontario. 9.0 APPENDICES 9.1 Appendix A Job Description Form 10.0 REVISION HISTORY SOP Date Number revised Author Summary of Revisions e1.0 Aug 2008 JDSH Initial release e1.0 Feb 2012 CMG Grammatical and formatting updates throughout. Removed the definition section Revision History moved to bottom of document Reference Links Updates Updated SOP references. Section 1: Deleted The procedures apply to all roles at the tumour bank. Section 3: Inserted Note that all CTRNet SOPs define roles and responsibilities. Copyright 2012 Canadian Tumour Repository Network (CTRNet). Page 5 of 7
6 Section 4: Deleted REB from the Tumour Bank Personnel list. Section 7.2: Inserted opening sentence. Section 7.2 (#3): Deleted Files samples in freezer (storage). Inserted enter consent information, and enter inventory information if appropriate. Section 7.2 (#5): Inserted Enters inventory information into the database. Section 7.2 (#8): Deleted #8, Physicians Associated with tumour bank program Section 7.2 (#9): Deleted #9, Porter Section 7.2 (#10): Deleted #10, Research Ethics Board Members Copyright 2012 Canadian Tumour Repository Network (CTRNet). Page 6 of 7
7 APPENDIX A JOB DESCRIPTIONS, ROLES AND RESPONSIBILITIES Job Description Form Job Description Form Position Title: Incumbent Name: Department: Location: Primary Purpose: 11.0 Essential Functions: 1. Responsibilities: Minimum Qualifications: Basic Competencies & Minimum Experience: Approved By Date Copyright 2012 Canadian Tumour Repository Network (CTRNet). Page 7 of 7
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