Tissue Bank Coordinator

Tissue Bank Coordinator

About Queen's University

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Job Summary
Reporting to the Manager, Pathology and Tissue Bank, the Tissue Bank Coordinator will coordinate, oversee, and ensure quality for the tumour/tissue banking operation of a national and international multicentre clinical trials group across the Phase I-III programs in cancer therapy. The Tissue Bank Coordinator will be responsible for coordinating activities related to correlative biology with Team Leads and Study Coordinators of the Canadian Cancer Trials Group (CCTG). Under the direction of the Manager, Pathology and Tissue Bank, the incumbent will be responsible for project execution and will provide coordination and direction for the technical teams in the Tumor Tissue Data Repository (TTDR), the external research investigators, the CCTG IT team and the TTDR Tissue Bank staff. The Tissue Bank Coordinator must maintain awareness and understanding of the ethical and regulatory guidelines, such as ICH-GCP and Tri-Council Policy Statement of the Ethical Conduct for Research Involving Humans.

Job Description
KEY RESPONSIBILITIES:
• Develop and maintain generic protocol sections and consent templates relating to correlative studies in collaboration with the Trial Management Group (TMG) and the Office of Compliance and Oversight (OCO).
• Provide support to study teams and to the OCO for issues which arise from research ethics boards or evolving ethical and regulatory requirements.
• Review all Investigational New Drug (IND) and Phase III protocols and sample consent forms for correlative biology studies and tumour/tissue banking content. Ensure consent is appropriate for biospecimen distribution to external parties.
• In collaboration with the trial team, ensure that a process for sample flow is in place prior to trial activation. Assist with the development of Laboratory Manuals to ensure consistence and quality.
• Participate in the ongoing maintenance and evolution of the TTDR/study specific database for consent, specimen acquisition, derivatives, and correlative biology results.
• Coordinate the process of computerized data retrieval with the computing and biostatistics team to prepare and analyze regular and standardized reports.
• Maintain, update and develop standard operating procedures for tissue banking, in compliance with regulatory and ethical guidelines. Coordinate in association with study teams a process flow for integrated or integral markers.
• Complete an ongoing review of work instructions (WKIs) and standard operating procedures (SOPs) related to the Tissue Bank, updating as required.

• Develop quality assurance and quality control (QA/QC) systems for biospecimens and determine appropriate methods to log QA/QC findings for all biospecimen types.
• Respond to queries regarding biospecimen receipt, logging, and errors from external sites, trial teams and Tissue Bank staff.
• Work with trial teams to develop kit contents; order supplies and oversee kit inventory; provide supervision for kit production associated with protocol specific correlative work.
• Assume responsibility for aspects of digital pathology as delegated by the Manager, Pathology and Tissue Bank.
• Maintain and develop tumour bank intranet and external website.
• Plan and develop abstracts and poster/paper presentations describing and promoting the activities of the bank. Develop educational material, and provide education to the staff and external participants of the Tissue Bank.
• Coordinate requests for access to the bank, for both protocol specified correlative studies and third party requests for use of tissue. Provide a liaison between study teams and lab services providers.
• Provide support to various committees within the CCTG. Improve the Correlative Science Project tracking database, update data, and improve communication between all parties.
• Ensure the tracking of Tissue Bank staff training, updating of certification, and updating/developing training procedures for all Tissue Bank staff.
• Provide updates and ongoing education to study teams as required to ensure knowledge and process is standardized across the organization.
• Undertake additional duties as assigned in support of the Tissue Bank and the CCTG.

REQUIRED QUALIFICATIONS:
• Master’s Degree in Health Sciences or equivalent program of study.
• Minimum 5 years of relevant experience in one or more of the following: clinical research, clinical trials, oncology or health science research. Experience in a medical, research or pharmaceutical setting, including laboratory experience is an asset.
• Consideration may be given to an equivalent combination of education and experience.

SPECIAL SKILLS:
• Respects diversity and promotes inclusion in the workplace.
• Excellent communication skills both written and verbal.
• Leadership and supervisory skills to enable duties and responsibilities.
• Ability to work independently as well as collaboratively with colleagues in both the TTDR, central office and centres across the country.
• Excellent organizational skills with strong attention to detail.
• Ability to set priorities and meet deadlines.
• Computer skills such as Oracle, Word, Excel, PowerPoint, RAVE and an understanding of databases.

DECISION MAKING:
• Review and create standard operating procedures and work instructions to ensure workflow, processes and quality are in place. Ensure efficient processes are in place for implementation, review, and updating as needed.
• Ongoing assessment of workload priorities.
• Ensure open and clear two-way communication.
• Ensure the TTDR is operating under current and relevant regulatory and ethical guidelines and apply these to the development of banking SOPs.
• Critically evaluate the content of protocols and consents with respect to planned and future correlative studies.
• Ensure consistency across the development of Correlative Laboratory Manuals.
• Identify improvement opportunities and address inconsistencies amongst study teams.
• Understand and interact with the contracts group regarding the development of Material Transfer Agreements for specimen use.
• Determine when a problem or accident is serious enough to warrant consultation with the Manager, Pathology and Tissue Bank.
• Decide how to answer questions from other labs or external agencies.

Employment Equity and Accessibility Statement

The University invites applications from all qualified individuals. Queen's is strongly committed to employment equity, diversity, and inclusion in the workplace and encourages applications from Black, racialized persons, Indigenous people, women, persons with disabilities, and 2SLGBTQI+ persons. In accordance with Canadian Immigration requirements, priority will be given to those who are legally eligible to work in Canada.

The University provides support in its recruitment processes to all applicants who require accommodation due to a protected ground under the Ontario Human Rights Code, including those with disabilities. Candidates requiring accommodation during the recruitment process are asked to contact Human Resources at View email address on clients.njoyn.com .