Job Description

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Reporting to the Manager, Pharmacy Oncology, the Oncology Clinical Trials Pharmacist is an integral member of the Pharmacy Team. The Oncology Clinical Trials Pharmacist is accountable and responsible for completing oncology clinical trials investigational product(s) assessments, ensuring optimal medication therapy and minimizing potential for adverse events. They are also accountable for providing accurate medication information to the interdisciplinary team within the Hudson Regional Cancer Program (HRCP). This information may also include funding and treatment guidelines as described by Ontario Health-Cancer Care Ontario (OH-CCO). The Oncology Clinical Trials Pharmacist will promote evidence-based/cost effective drug therapy, will promote clinically relevant research and be involved in educational activities for students, families and staff. The Oncology Pharmacist will work with chemotherapy Pharmacy Technicians to ensure safe medication practice and drug delivery within the Oncology Pharmacy. Ongoing collaboration and communication within the healthcare team and with the pharmacy team is essential.

Education and Licensing:

Registered Pharmacist, in good standing with the Ontario College of Pharmacists (Part A) Bachelor of Science degree in Pharmacy (PharmD, an asset) Essentials of Oncology for Pharmacists (U of T), preferred - required within one (1) year of hire Advanced Oncology for Pharmacists (U of T), an asset - required within five (5) years of hire Clinical Trials education and training (Canada GCP, Health Canada Division 5, Network of Network Standard Operation Procedures)

Experience:

Post-graduate Pharmacy Residency Program (ACPR), an asset Minimum of two (2) years of experience in a hospital pharmacy setting, preferred Minimum of two (2) years of experience in pharmacy oncology, an asset Minimum of two (2) years of experience in an oncology clinical trials pharmacy setting, required

Competencies:

Strong knowledge of protocol review, impact analysis creation, study feasibility, and clinical trials standards and regulations (GCP, Division 5, etc.) A main focus of this role is to ensure the effective processing, storage and documentation of the investigational products, safeguarding compliance with relevant regulatory guidelines. Knowledge of current evidence-based, best practice pharmacotherapeutics & pharmacokinetics and their application to patient-centered pharmaceutical care Practice continuing professional development as required by Regulated Health Professions Act Knowledge of disease states with focus on the specialty service of oncology (e.g. solid and liquid tumours) Knowledge of CCO, including QBP and NDFP funding models Knowledge of appropriate dosages, delivery techniques, formulations and routes of administration of antineoplastic drugs Knowledge of hazardous sterile compounding procedures as described in the NAPRA standards Knowledge of acute and long term antineoplastic drug toxicities Knowledge & interpretation of laboratory and clinical parameters and their application to patient assessment & monitoring Knowledge & utilization of credible electronic & print form medical information resources Knowledge of third party reimbursement strategies Knowledge of strategies to minimize risk of errors with chemotherapy drugs Knowledge of health promotion & disease prevention Knowledge of complementary medicines & alternative therapies Knowledge of multiculturalism and diversity Knowledge of Microsoft applications Understanding and interpretation of research methodology and outcomes & critical appraisal of study design Excellent time management and organizational skills Ability to function as an independent practitioner Sound problem solving, communications (oral and written), conflict resolution and decision making skills Highly motivated team player with the ability to collaborate across disciplines/departments/programs Ability to perform multiple tasks and work under pressure Contribute to a strong teamwork environment Excellent attendance, punctuality and employment record

Responsibilities:

Reviews and identifies any protocol discrepancies that impact oncology pharmacy Identifies problems in the execution of protocols and seeks resolution of same. Participates in pre-site selection meetings to ensure early identification of investigational product issues and funding. Participates in site activation, steering committee meetings, Formulates/develops procedures to carry out protocol objectives accurately Create clinical trials treatment regimens in computerized physician order entry system Responsible for creation and submission of OH-CCO Clinical Trials Intake Form (when site is Provincial Applicant) Responsible for assessing the impact on protocol amendments, updated Investigator Brochures, SmPCs, and Toxicity Management Guidelines on regimen build, oncology pharmacy staff training and any impacts to IP Ensures chemotherapy dose adjustments are carried out according to protocol Receive, log and document investigational products according to established protocols Oversight of investigational product inventory, monitor expiry dates, temperature excursions and disposal of expired inventory + Collaborate with the rest of the team to ensure the availability of investigational products for ongoing clinical trials. + Prepare the investigational product for study protocols, including reconstitution and dilution as required. + Troubleshoot issues related to investigational product handling and escalate to appropriate personnel when necessary. + Ensure optimal communication and collaboration with the clinical trials team, sponsor, CRO, monitors and auditor with any IP related inquiries. + Stay updated on relevant regulation, guidelines, and developments in the field of clinical research. Complete patient medication assessments and oncology chart review including in depth analysis of drug/drug interactions that may preclude study enrollment Ensure optimal medication therapy and minimization of potential adverse events. Review of lab information to ensure appropriate oncology drug therapy. Ensure guidelines and funding criteria are followed as per OH-CCO Participate in multidisciplinary rounds as required. Participate in drug distribution, including accurate order entry of physician orders. Provide pharmacists and other healthcare professionals with acquiring relevant drug information. Create and implement clinical trials oncology pharmacy training which may include but not limited to: Clinical Trials Summary Summary of Investigational Product(s) Oversight of training Actively review and provides recommendations on various document submissions relating to clinical area of coverage. Work collaboratively with interdisciplinary team at HRCP Participate in the education and mentoring of pharmacy students and new staff. Participate in the education and ongoing learning of nursing staff. * Other duties, as assigned.