Job Summary The Specialty Pharma Nurse, Clinical Trials Registered Nurse (CTRN) reports directly to the Specialty Pharma Nurse Supervisor (SPNS) and/or Specialty Pharma Nurse Manager (SPNM). In this role, the CTRN works in close collaboration with the Scientific Affairs (SCA) team to deliver and monitor specialized infusion, injectable or oral pharmacological treatments, investigational medicinal products in the home and/or clinic setting.

The CTRN administers protocol-specific nursing care to participants in home, clinic, or community settings within decentralized or hybrid trials. This position upholds patient care standards, ensures strict protocol and regulatory compliance, and serves as the primary liaison for the sponsor and study team in the participant’s environment.

The CTRN is responsible for monitoring the patient for clinical trial study related reactions (intervening as required or directed by protocol), accurately documenting the procedure on electronic charts or clinical trial source documentation and submitting reporting in a timely manner. The CTRN is expected to maintain effective communication with the SPNS and/or SPNM along with the Scientific Affairs Team to ensure patient safety and satisfaction. Specialized pharmacological or clinical trial training will be provided.

This role offers the opportunity to specialize in clinical trial support and actively contribute to clinical research initiatives.

Bayshore has a focus on nursing education and provides many opportunities for nurses to advance their professional growth.

A minimum commitment of two days per week, Monday through Friday, is required. Bayshore will work with you to assemble a working schedule that fits your lifestyle. CTRN is a one-on-one patient experience, and we strive to ensure that patients stay with the same nurse to ensure the best quality and continuity of care.

Duties And Responsibilities

• This role requires the nurse to complete all training mandated by clinical trial protocols and regulations, including extensive theoretical instructions.
• Ensure compliance with Good Clinical Practice (GCP), International Counsel of Harmonization (ICH) guidelines, Standard Operation Procedure (SOPs,) and local regulatory requirements
• Develop and review nursing care plans that are individualized to each patient;
• Conducts patient health assessments and medication administration teaching;
• Demonstrated competency in phlebotomy including venipuncture across diverse patient populations;
• Perform lab sample processing, packaging, centrifuge operation and shipment in accordance with protocol, dangerous goods and sponsor requirements;
• Coordination and management of courier services for biological sample collection, study medication deliveries, and study supplies in accordance with protocols and temperature requirements;
• Obtain IV access through peripheral IV initiation or central line access (PICC, IVAD, etc.) from patients of all ages;
• Prepares and administers a variety of specialized or investigational medicinal product intravenous or injectable pharmacological treatments from patients of all ages, per protocol;
• Conducts other protocol assessments including but not limited to ECGs, Spirometry, limited physical assessments, electronic patient reported outcomes (EPROs);
• Provide patient care by utilizing the skills of observation, assessment, nursing diagnosis, counseling, health teaching, and reporting any adverse events to immediate supervisor or required stakeholders;
• Perform routine nursing duties in accordance with company policies and procedures, and provincial body standards;
• Ensure accurate, timely and protocol-compliant documentation to support data integrity and contractual obligations;
• Provide patient centered care according to the established care plan or medical directive;
• Perform specialized nursing procedures for which recognized training and current competencies have been demonstrated and updated per standards;
• Maintain role related training and updates as required;
• Observe and document patient conditions;
• Report and document Adverse Events as per Pharmacovigilance requirements;
• Complete all other duties as requested.

Qualifications Education

• Graduated from an accredited nursing education program with a Bachelors of Science in Nursing (BSN) degree or equivalent;

• Current registration and in good standing with provincial nursing regulatory body;

• Current Basic Cardiac Life Support (BLS) certification;

• Current Advance Cardiac Life Support (ACLS) certification is an asset;

• Current PALS certification is an asset;

• Knowledge or certification in Good Clinical Practice (GCP), Dangerous Goods Transportation, Division 5 Health Canada Regulations is an asset.

• If the required qualifications are not possessed by the successful candidate; the candidate will be required to obtain certification necessary for the location of their work.  Training for the certification will be completed on the successful candidates own time. **

Experience

• Minimum 2–3 years of clinical nursing experience;

• Experience in acute care and/or with administering specialty pharmaceuticals;

• Experience with patient population of all ages, including pediatrics is an asset;

• Experience with home care and/or clinical research is an asset;

• Critical care (e.g., ER or ICU) is an asset;

• Exceptional peripheral IV initiation and phlebotomy skills;

• Experience with central lines (IVAD, PICC, etc.) is required;

• Demonstrated experience with crisis management, adaptability, escalation procedures and independent clinical decision making in high-acuity or unpredictable environments.

Other Skills And Abilities

• Exceptional patient assessment skills;
• Strong communication skills;
• Willingness to travel long distances;
• Able to manage relationships with exceptional customer service;
• Utilize telehealth platforms and electronic tools for remote assessments and documentation;
• Exceptional interpersonal skills and ability to handle difficult situations;
• Able to work independently and as part of an interdisciplinary team;
• Able to perform and prioritize multiple functions and tasks;
• Able to read and interpret technical instructions related to patient care;
• Able to transcribe physician’s orders;
• Ability to safely lift, transport and handle clinical trial supplies and equipment;
• Valid drivers license with ability to travel to patient homes, clinics as required;
• Comfortable working independently in fast-paced, evolving clinical trial environments with minimal supervision;
• Specifically for the province of Quebec - English is an asset

Primary Location ON-Toronto