The Clinical Trials Registered Nurse (CTRN) works in collaboration with Oncology Investigators and multi-disciplinary clinical & enabling teams in the overall management & coordination of patients participating on clinical trials at Trillium Health Partners Carlo Fidani Regional Cancer Centre. Studies include industry and cooperative group (such as CCTG) sponsored, Medical, Radiation & Surgical Oncology trials in a variety of disease sites including but not limited to Breast, GI, GU, Gyne, Lung, and Melanoma.
Key responsibilities include recruitment (incl. screening, consenting & enrollment) of study participants; coordination of clinic visits & treatment administration visits as per study protocol; assessment & monitoring of adverse events as per applicable Common Terminology Criteria for Adverse Events (CTCAE) guidelines & supportive medications using standardized criteria; provision of clinical care, support & education to study participants; ensuring strict adherence to protocol requirements (incl. questionnaires, sample collection, etc.) as well as the completion of required source documentation, applicable case report forms & queries in accordance with the policies & practice standards of Trillium Health Partners (THP), the College of Nurses of Ontario (CNO), all relevant clinical trials regulations (ie. Health Canada, FDA, TCPS), Legislation (ie. privacy) & ethics approved clinical trials protocols.
The Clinical Trials Nurse will also participate in study feasibility reviews; Epic treatment builds; planning & implementation of study-specific workflows; monitoring visits & audits; facilitate study-specific in-service/education sessions for clinical teams (as required); as well as contribute to corrective & preventative action plans and departmental process improvement initiatives.
This specialized role requires a deep knowledge & understanding of cancer, oncology nursing skills, and the ability to act as a strong patient advocate within the complex regulatory framework of clinical trials.
Key Qualifications:
Registered Nurse with a minimum of 3 (three) years experience
BScN or recognized equivalent (ie. BN)
Current Registration with the College of Nurses of Ontario
Minimum one (1) year experience in oncology with a knowledge base in Breast, GI, GU, Gyne, Lung, Melanoma Oncology
Current BCLS certification
Canadian certification in oncology nursing (CON(C)) obtained or planning to work towards
Prior work experience in Phase II, III or IV trials preferred
Recognized certification in clinical research (ACRP or CCRP) or planning to work towards
Knowledge & application of ICH GCP guidelines, TCPS2, Health Canada Division 5
Knowledge of IATA shipping regulations & basic laboratory procedures is an asset
Demonstrated knowledge and ability to use the nursing process in planning, implementing and evaluating patient care
Excellent patient assessment and teaching skills
Demonstrated attention to detail & meticulous documentation practice essential
Excellent organizational and time management skills required
Strong analytical and problem-solving skills
Demonstrated ability to think critically & manage changing priorities in a dynamic environment
Excellent interpersonal, verbal & written communication skills required
Aptitude for continuous learning
Ability to work independently as well as a cohesive member of a multidisciplinary team
Proficiency with MS Office applications (ie. Outlook, Excel, Word, Powerpoint)
Experience with clinical research applications & eCRFs (ie. IVRS, ADEERs, MEDIDATA, RAVE, InFORM, etc.) preferred
Experience with Electronic Medical Record Software (ie. EPIC)
* Ability to attend off-site meetings as required
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