Clinical Research Project Coordinator - Clinical Trials Support Unit

Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) is one of the largest and most respected paediatric healthcare centres in the world. As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading-edge research and education. Our reputation would not have been built - nor could it be maintained - without the skills, knowledge and experience of the extraordinary people who come to work here every day. SickKids is committed to ongoing learning and development, and features a caring and supportive work environment that combines exceptionally high standards of practice.

When you join SickKids, you become part of our community. We share a commitment and determination to fulfill our vision of Healthier Children. A Better World.

Don't miss out on the opportunity to work alongside the world's best in paediatric healthcare.

Position Description:

We are currently looking for a Clinical Research Project Coordinator (CRA II) to join the Clinical Trials Support Unit (CTSU) team, part of the Haematology/Oncology program at SickKids. In this role you will manage consortium, investigator initiated and/or industry-sponsored clinical trials. You will work collaboratively with a multidisciplinary oncology team of physicians, nurses, clinical research project coordinators and managers, and more. You will also be developing strong relationships and collaborating with external stakeholders including study sponsors, C17 Council, and all other 16 pediatric oncology/BMT/CT programs across Canada. You will be responsible for the coordination of various aspects of clinical research trials including regulatory work, patient enrollment, data submission, aspects of study activation and more. This is an exciting opportunity for you to use your project management skills and clinical trial knowledge to facilitate consortium, investigator-initiated and industry-sponsored clinical research trials in a dynamic and fast-paced oncology setting. Don't miss out on the opportunity to work alongside the world's best in paediatric cancer healthcare.

Here's What You'll Get to Do:

• Prepare and submit regulatory documents (i.e., amendments, consent forms, REB application packages etc.) for ethics review throughout lifecycle of the study
• Screen, consent patients and enroll eligible patients on study as per study protocol
• Monitor study compliance, collaborate with clinical staff to assure completeness and accuracy of documentation, facilitate use of the protocol as well as maintain quality assurance through accurate and timely data reporting
• Monitor serious adverse events or reactions, and report immediately to Principal Investigator. Follow-up on adverse events according to SickKids' Policy. This includes filing reports with internal (REB), sponsors, external regulatory bodies and/or patients.
• Conduct study feasibility review; assist with tracking study budgets, closely collaborating with the budget associate, as necessary
• Liaise with other clinical research coordinators (CRCs) and managers, research nurses, physicians, other members of the clinical team and regulatory personnel to ensure patient management and oversight of regulatory components of clinical trials
• Responsible for study data abstraction and submission in accordance with sponsor and other regulatory timelines.
• Work with the legal and contracts department within SickKids to ensure clinical trials contracts and other documents are in place
• Participate in process improvement initiatives, including development of new SOPs and other processes for more efficient conduct of clinical trials in accordance with institutional and regulatory requirements
• Participate in sponsor audits and inspections and contribute to audit preparatory work, as needed
• Specimen submission: shipment of clinical trial tissue and blood samples
• Participate in educational initiatives concerning clinical trials and attend related meetings
• Be an active member of the interdisciplinary team; collaborate and problem solve effectively
• Build strong relationships with all (internal and external) stakeholders; maintain positive and productive work relationships
• Contribute to other areas and functions of the team, as necessary

Here's What You'll Need:

Essential

• Baccalaureate degree in a related discipline (i.e., Life Sciences or equivalent) required
• Minimum of 2 years related experience in clinical trials, including industry-sponsored, academic or investigator initiated interventional clinical trials
• High energy individual with positive attitude
• Excellent attention to details, organizational and time management skills
• Demonstrated exceptional interpersonal and communication skills
• Demonstrated ability to utilize critical thinking and problem-solving abilities with analytical skills
• Strong computer skills including experience with various electronic data capture systems
• Self motivated and able to work independently as well as within a team
• Ability to work under pressure and able to multi-task & perform in a fast-paced environment
• Demonstrated commitment and actions in advancing equity, diversity and inclusion objectives

Assets

• Certification as a Clinical Research Professional or eligibility to obtain certification
• Clinical Research Program College Certificate or a university Masters degree
• Prior experience in paediatric oncology and early phase trials
• Knowledge of medical terminology is required. Prior experience in a hospital or cancer program setting
• Prior research and/or work experience in a hospital environment
• Prior experience in oncology

Employment Type:

• Full time, permanent position
• This is a hybrid role, which will require on-site presence at SickKids(60-80% of the time), with an opportunity to work from home a few days per week, depending on study activities and needs of the section.

Instructions: For LinkedIn users, applications submitted through LinkedIn cannot be processed. If interested in this role, applications should be submitted through the SickKids Career website https://www.sickkids.ca/en/careers-volunteer/careers/ .

SickKids is committed to championing equity, diversity and inclusion in all that we do, fostering an intentionally inclusive and culturally safe environment that reflects the diversity of the patients, families and communities we serve. Learn more about workplace inclusion.

If you require accommodation during the application process, please reach out to our aSKHR team. SickKids can provide access and inclusion supports to eligible candidates to support their full engagement during the interview and selection process as well as to ensure candidates are able to perform their duties once successfully hired. If you are invited for an interview and require accommodation, please let us know at the time of your invitation to interview. Information received related to access, inclusion or accommodation will be addressed confidentially.

Technical difficulties? Email [email protected] with a short description of the issues you are experiencing. We will not accept resumes sent to this inbox but we are happy to respond to requests for technical assistance.

Tip: Combine your cover letter and resume into ONE document of 20 pages or less as you cannot upload multiple documents as part of your application.