Clinical research Associate
Building healthy communities through outstanding care, innovative partnerships, and amazing people.
Join our team and together we will forge a new path to meet the changing needs of our growing communities and champion a culture of exemplary care to deliver clinical excellence by creating an environment where the best experiences happen. Through new partnerships, a relentless focus on quality and sustainability, and a dedication to the best patient and provider experience, Southlake will improve the health of our communities and shape the future of healthcare.
The Clinical Research Associate (CRA) will collaborate with Investigators and health care team to assume responsibility for the overall patient management and coordination of several oncology clinical studies for the clinical trials department at Stronach Regional Cancer Program. Responsibilities include recruitment of study participants (e.g. identify and screen potential eligible patients, obtain informed consent); coordination of patient visit schedules as per study protocol; execution of all aspects of study visit (e.g. assessment adverse events, monitoring safety, medication, questionnaires, sample collection, provides clinical care for patients participating in clinical trials and the implementation and coordination of all aspects of data collection and source documentation as per SRHC/REB policy and ICH/GCP guidelines. The CRA will work primarily with all variety of oncology clinical trials. Studies include Industry-sponsored, cooperative group sponsored (such as CCTG) as well as Investigator initiated trials.
• Post Secondary education in a Health Science field of study is required
• Bachelor of Science (BSc.) preferred
• Recognized certification in clinical research (ACRP or SOCRA) obtained or plan to work towards
• 2 years related experience, in an oncology clinical research setting, or equivalent combination of education and experience.
• 2 years' experience in clinical research conducting oncology clinical trials, registering eligible patients, and interacting with patients and their families following patient-centered care model.
• 2 years' experience explaining details and requirements of the trial design to patients and or family.
• Strong knowledge base of oncology clinical trials
• Advanced knowledge of the current regulatory environment in Clinical Research
FDA – Code of Federal Regulations
FDA Audit procedures
Health Canada Clinical Trial Applications (CTA)
Health Canada inspections procedures
CCTG monitoring and audits
• Ability to set priorities and work independently with accuracy in a dynamic environment
• Ability to read test results (i.e. pathology, radiology, cytology, biochemistry) and identify appropriate medical reports.
• Advanced knowledge related to CRF,eCRF, PRO and ePRO,
• Experience in completion of ethics/regulatory submissions.
• Demonstrated ability to prioritize workload, with particular attention to detail.
• Proficient in MS Windows environment (Word, Excel, Power Point).
• Relevant oncology clinical trials experience preferred.
• Innovative and willing to learn
• Demonstrates individual leadership skills and autonomous critical thinking ability
• Demonstrated excellence in communication, both written and verbal
• Demonstrated problem assessment skills
• Demonstrated commitment to customer service and teamwork
• Demonstrated individual leadership skills
At Southlake Regional Health Centre, we are committed to fostering an inclusive and accessible environment. We are dedicated to building a workforce that reflects the diversity of the community in which we live and serve, including those with disabilities. Southlake Regional Health Centre is committed to providing accommodations in all parts of the hiring process. If you require an accommodation, we will work with you to meet your needs.
It is the responsibility of all Southlake Regional Health Centre employees to work in a safe manner and promote health and safety in the workplace.
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