Applications will be accepted until 11:59 pm on 2025 July 21

Title: QA & Research Specialist - Stem Cell

Department: Stem Cell Transplant Program

Position Number: 50073793

Hours of Work: Full-Time Position; Days Shift

Salary: Class 04 - $74,994-$89,994

Union: Non-Union

Location: Kingston General Hospital Site

PRIMARY FUNCTION

Under the direction of the Quality Assurance Manager, Stem Cell Transplant & Cellular Therapy Program and the Clinical Program Director, Stem Cell Transplant & Cellular Therapy Program, the Quality Assurance & CIBMTR Research Data Specialist, is responsible for the development, organization, and operational aspects of relevant patient and support databases for transplant and cellular therapy recipients, as well as the coordination of research studies (i.e. Center for International Blood and Marrow Transplant Research (CIBMTR)) undertaken by the Stem Cell Transplant & Cellular Therapy Program. Primary function involves: obtaining all necessary approvals for the research studies, entering data/query and any other research/trial related duty assigned to ensure that the research is conducted efficiently, accurately, and in compliance with applicable policies, procedures, and regulations.

This position will also oversee and report/share research metrics, milestone reports & deliverables that may be reported within the institution or external agencies and assist in corrective actions plans to ensure targets will be met.

In addition to research duties, the Quality Assurance & Research Data Specialist is responsible to support operations of key areas of the Program to ensure efficient, safe implementation of practice and procedure standards, including the development, implementation and maintenance of quality program documentation. Ensures quality documentation is prepared and controlled in accordance with applicable quality program requirements, including Standard Operating Procedures and other critical documents. Supports the Quality Assurance Manager with internal and external auditing processes and quality activities to meet requirements for governing/accrediting bodies and the Program’s Continuous Quality Management Program.

Administrative support to the program as required.

The Quality Assurance & Research Data Specialist fosters an environment that promotes safety and quality assurance practices, including effective change management. Within this role the employee is accountable for contributing to the delivery of the Kingston General Hospital strategy. As an employee, one must demonstrate an awareness of and be responsible for actively promoting and supporting patient and family centered engagement and care in all we do.

RESPONSIBILITIES & DUTIES:

• Supports the development, implementation, and maintenance of all necessary Standard Operating Procedures (SOPs) and critical documents required by the Program to adhere to required laws, Health Canada regulations, and Foundation for the Accreditation of Cellular Therapy (FACT) Standards; works collaboratively with input from Stem Cell Transplant & Cellular Therapy Program staff.

• Confirm consent has been obtained, entering data/query and any other transplant essential data collection related duty assigned to ensure that the Data collection is conducted efficiently, accurately and in compliance with applicable policies, procedures and regulations. Review of clinical charts in order to abstract required data including test results and medical reports to complete and submit transplant and cellular therapy essential data forms in timely manner (e.g. as per CIBMTR timelines) and respond to data queries from external agencies on previously completed data submission.

• Act as a primary point of contact for transplant and cellular therapy essential data form related questions within the Program for up 100 days (standard of care); including providing form question(s) specific direction or locating appropriate resources/responses from external agencies (e.g. CIBMTR).

• Standard of Care (up to 100 days): Liaise with internal and external personnel to obtain information and data required for CIBMTR transplant and cellular therapy essential data submission; liaise with transplant team members, Medical Secretary, and Nurse Navigator to ensure necessary scans, biopsies, test, etc., are booked and documented in the clinical chart or that requests for information have been submitted, contact outside health professionals (i.e. family doctors, primary hematologists/oncologists) and healthcare organizations to obtain information on test(s) results, or status of the patient as needed).

• Ensures appropriate document control processes are followed within the Stem Cell Transplant & Cellular Therapy Program.

• Review and evaluate program data quality through internal auditing, make recommendations for improvement and/or implement improvements in concert with Quality Assurance Manager.

• Provides leadership and consultancy on research/data collection practices to colleagues within (multidisciplinary team) and outside the organization. Monitor the quality and performance of data collection, applying quality assurance, privacy, statistical analysis principles, and theories.

• Improves data collection and submission practices through the development, implementation, and evaluation of guidelines/worksheets, orientation and training resources for clinical staff, data entry source documentation database(s), policies and standard operating procedures that promote excellence in research/data quality. Undertake continuous improvement initiatives by re-evaluating processes and procedures to ensure the most effective use of resources, including submission of corrective action plan(s) to external agencies (e.g. CIBMTR).

• In collaboration with the Quality Assurance Manager, assists the Program in knowledge regarding critical documents including, but is not limited to:

• Organizational structure of the program
• Standard Operating Procedures
• Personnel qualifications, training, and competency requirements
• Outcome analysis and review of engraftment data
• Internal Quality Audits
• Detection and reporting of errors, accidents and adverse events
• Critical document review and document control
• Product tracking and tracing
• Validation of reagents, equipment, and procedures
• Qualification of facilities, reagents, supplies and equipment

• Supports internal audit processes and scheduling. Ensures, with guidance from the Quality Assurance Manager, that action items from internal audits and quality meetings are completed in a timely manner.
• Supports Research (e.g. CIBMTR) and FACT assessment and readiness activities, as required

• Supports education on standards and regulations, as required
• Supports processes of self-assessment, including internal quality assurance audits
• Supports the process for FACT compliance application and on-site or virtual inspection

• Administrative support to the program as required.

NOTE - The above duties are representative but are not to be construed as all-inclusive.

BASIC QUALIFICATIONS:

• 3 year post-secondary diploma in general science field.

• Basic knowledge of anatomy physiology, and medical terminology.

• Baccalaureate degree in nursing, biostatistics, chemistry, biology, epidemiology, computer science, or social sciences or health-related field (preferred).

• Current certification in good clinical practice (GCP) preferred and re-certification as required.

• 1-2 years minimum in the past 5 years in CIBMTR transplant and cellular therapy essential data collection and reporting, research, or quality or

• A minimum of 3 years clinical trial conduct experience in the last 5 years in clinical research environment required.

• Project management experience preferred.

• Data entry and analysis experience preferred.

• Research and Bioethics (CITI) training preferred.

• Health Canada Division 5 preferred and re-certification as required.

• Proficiency in Medical terminology (to be tested).

• Knowledge of international, federal, and provincial laws and regulations governing clinical research and Program accreditation.

• Highly computer literate with demonstrated proficiency in Windows based applications (Word, Excel, PowerPoint, Teams), email, computerized calendars, and intranet/internet, and other data/computer systems.

• Demonstrated ability to develop and maintain a range of computerized databases.

• Demonstrated knowledge of clinical charting and health record systems.

• Ability to work independently with minimal supervision.

• Ability to prioritize, delegate, and oversee workload for self and others.

• Demonstrated ability to prioritize, think critically, and problem solve.

• Excellent time management and organizational skills for management of competing priorities, deadlines, and time-sensitive issues.

• Ability to work well under pressure and in stressful situations and discretion in handling sensitive and/or confidential information.

• Experience in development and delivery of staff education materials.

• Ability to work in a multi-task, multidisciplinary area, and fast-paced environment.

• Excellent interpersonal skills and demonstrated ability to communicate.

• Demonstrated ability to attend work regularly.

• Strong analytical skills and organizational skills.

• Training in CIBMTR and/or experience in transplant and cellular therapy essential data reporting requirements.

• Knowledge of FACT Standards for both Clinical and Collection Programs.

• Proven ability to attend work on a regular basis.

• Satisfactory criminal record check and vulnerable sector search required.

PHYSICAL REQUIREMENTS:

The applicant must be able to meet the physical demands of this position.

KHSC is located on the ancestral lands and waters of the Anishinaabeg and Haudenosaunee and serves a wider geographical area that encompasses many Indigenous communities including Tyendinaga, Katarokwi, as well as communities within the Weeneebayko Area Health Authority. As we partner in care, discovery, and learning to achieve better health outcomes for our communities, KHSC is committed to actively advocating for and acting upon the Truth and Reconciliation Committee’s Calls to Action on Health.

KHSC is committed to recruitment practices that support and contribute to building a respectful, diverse and inclusive workplace. We welcome all applications from women, racialized persons, persons with disabilities, Indigenous Peoples, persons in the 2SLGBTQIA+ community, and members of other equity deserving groups.

We thank all applicants, but only those selected for an interview will be contacted. Kingston Health Sciences Centre is committed to inclusive and accessible employment practices. If you require an accommodation to fully participate in the hiring process, please notify the Recruitment Team.