Clinical Research Associate Nurse, Children's Oncology Group

Nova Scotia Health and IWK Health•Halifax, NS

5d•CA$41 - CA$52•Onsite

About The Position

IWK Health is a respected academic health sciences centre located in Halifax, Nova Scotia, providing tertiary and primary care for two million children, youth, adults, and families each year across the Atlantic region. We have a team of approximately 4000 employees, physicians, volunteers, and learners at sites across Nova Scotia. People build careers with IWK Health with our focus on training and mentorship opportunities. We recognize each other’s talent and celebrate our successes. We collaborate in modern facilities or virtually from home, align our work to our values, and enjoy access to enhanced benefits and wellness programs. We are proud to support our patients, families, and communities and are grateful for the generous donor support we receive. Promoting an anti-racist environment and calling out discrimination as we work and provide care is important to us. We are located in Mi’kma’ki, the unceded and ancestral territory of the Mi’kmaq people. Working in Mi’kma’ki and providing care to those across Atlantic Canada is a shared privilege with the original inhabitants who have lived here for many thousands of years prior to colonization. There are 13 First Nation communities across Nova Scotia, and more than 50 historic African Nova Scotian communities that also have a long, deep, and complex history dating back over 400 years. We have the highest percentage of people with disabilities in the country. Nova Scotia has the highest proportion of transgender and non-binary people of any other province or territory in the country. We are active in our work to eliminate discrimination, but we have more work to do to build that trust, acknowledge our biases, and reduce the barriers our diverse communities face. We want IWK Health to be a safe and supportive space of equity and belonging in the care we provide and the employment we offer. We welcome all interested persons who self-identify as Indigenous, Black/African Nova Scotians, Persons of Colour, Immigrants/Newcomers, Persons with Disabilities, and 2SLGBTQIA+ to apply to support our goal for our workforce to be representative of the patients, families, and communities that we care for at all job levels. The OpportunityReporting to the Manager of the Hematology/Oncology/Nephrology/PACT service and the Children’s Oncology Group (COG) Principal Investigator, the Clinical Research Associate (CRA) Nurse is responsible for facilitating and coordinating COG clinical trial activities to ensure local/national/international human research requirements are fully met. The CRA Nurse works within an interdisciplinary team to ensure integration of research into clinical practice. The CRA works in collaboration with the Principal Investigator (PI), other research associates, the manager, and clinical care team to ensure clinical research opportunities are made available whenever possible, and that data collection is managed and submitted as per regulatory requirements. The CRA reviews all new COG protocols to determine the feasibility of opening the trial at IWK, liaises and seeks approval with other departments within the IWK to determine the feasibility of the protocol, and maintains the regulatory integrity of studies. The CRA participates in the REB process and ensures all amendments, action letters, and safety reports are reviewed by the appropriate people. Other responsibilities include but are not limited to: data management, confirmation of eligibility criteria for all patient registrants, verification of informed consent prior to patient enrollment, communication and facilitation of pretreatment requirements to clinical staff, registration of all newly diagnosed malignancies, creating and maintenance of a research chart, extraction and review of study data for completeness, accuracy and compliance, performing quality checks and regular audits, resolving queries and data discrepancies and the submission of required documents to the study directed location. Cross-training for intermittent CRA coverage within the COG office is an expectation of the position. The CRA Nurse practices according to the Canadian Nurses Association Code of Ethics for Registered Nurses, the College of Registered Nurses of Nova Scotia Standards of Nursing Practice, specialty standards as applicable, and the policies and procedures of the IWK. Practice will also be in accordance with a multitude of regulatory bodies such as Good Clinical Practice requirements, Health Canada, Food and Drug Act USA, Children’s Oncology Group, drug industry requirements, C17, and IWK Research Ethics Board (REB) and the NSHA REB. Appropriate certification will be required.

Requirements

Bachelor's Degree in Nursing required
Licensed or eligible for licensure by the Nova Scotia College of Nursing (NSCN)
5 years’ Experience in Hematology/Oncology required
Current successful completion of a Heart and Stroke Foundation of Canada Basic Life Support Level (BLS) Program within the last 12 months, or successful completion of a BLS Renewal Challenge Certificate, is required.

Nice To Haves

Pediatric experience preferred
Experience in clinical research preferred
Familiarity with data extraction and database entry preferred
Hematology/Oncology certification or enrollment in certification process preferred
COG member preferred
Experience using the ROMEO research portal and Microsoft Office preferred
Completion of Good Clinical Practice Guideline, Health Canada Division 5, Tri Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), and NIH Protection of Human Research training preferred
Proven ability to work as a member of an interdisciplinary team
Demonstrates strong organizational, communication, and interpersonal skills with patients, families, and colleagues
Demonstrates ability to be organized, proactive, and pay close attention to detail
Proven ability to navigate complex information and multitask
Proven ability to be flexible and responsive to changing priorities
Experience creating Word documents, such as policies, Standard Operating Procedures, and research regulatory forms, is an asset
Competencies in other languages are an asset

Responsibilities

Facilitating and coordinating COG clinical trial activities to ensure local/national/international human research requirements are fully met.
Working within an interdisciplinary team to ensure integration of research into clinical practice.
Collaborating with the Principal Investigator (PI), other research associates, the manager, and clinical care team to ensure clinical research opportunities are made available whenever possible, and that data collection is managed and submitted as per regulatory requirements.
Reviewing all new COG protocols to determine the feasibility of opening the trial at IWK.
Liaising and seeking approval with other departments within the IWK to determine the feasibility of the protocol.
Maintaining the regulatory integrity of studies.
Participating in the REB process and ensuring all amendments, action letters, and safety reports are reviewed by the appropriate people.
Data management.
Confirmation of eligibility criteria for all patient registrants.
Verification of informed consent prior to patient enrollment.
Communication and facilitation of pretreatment requirements to clinical staff.
Registration of all newly diagnosed malignancies.
Creating and maintenance of a research chart.
Extraction and review of study data for completeness, accuracy and compliance.
Performing quality checks and regular audits.
Resolving queries and data discrepancies.
Submission of required documents to the study directed location.
Cross-training for intermittent CRA coverage within the COG office.