TECHNICIAN, CLINICAL OPERATIONS
Apotex - Toronto, ON
This job posting is no longer available on Apotex.
Responsible for assisting with the conduct of activities related to screening, pre-study support, pre-study/ In clinic activities, and post-study support as required. This includes the documentation and data entry of all study information.
Key Job Responsibilities
1. Screening activities:
2. Pre-study support:
- Performs 12 lead Electrocardiograms (ECGS), vital signs, Height/Weight and Elbow Breadth Measurements
- Processes Blood and Urine samples to be transferred to the diagnostic laboratory
- Processes urine samples for the purpose of screening potential volunteers for drugs of abuse and/or nicotine
- Conducts screening interview and Assesses volunteer eligibility
- Presents Screening consent, study information and Clinic Rules and Regulations
3. Pre-Study/In Clinic Activities:
- Stocks screening and clinic supplies as needed
- Conducts Clinic/Screening set-up, and labelling
4. Post study support:
- Conducts volunteer compliance interview, volunteer reweigh, urine drug screen for drugs or abuse and/ or nicotine and pregnancy testing as required
- Performs 12 lead ECGs, vital signs and glucometer testing
- Conducts meal/fluid distribution, monitors clinical activities, and assembles subjects to ensure timing of all clinical events
- Processes subject samples as required
- Performs Waste Management of the chemical and biohazard waste
- Conducts sample sorting and sample transfer
- Photocopies documents as required
Relationship with Internal/External Customers & Stakeholders
- Interacts with volunteers/subjects to provide screening/study information as required
- Cooperates with and supports the activities of auditors/inspectors
- Interacts with volunteers/subjects in a respectful, professional and courteous manner in the performance of day to day activities
Problem Solving Analysis
- Performs basic problem solving techniques in the performance of day to day activities
- Provides solutions to improve: Screening/Clinic logistics, customer service for the volunteers/subjects, training, and processes and procedures.
- Prioritises responsibilities in such a manner that allows all screening/clinical events to occur in a timely manner
Leadership/Professional Development of Self & Others
- Participates in ongoing educational activities to enhance own knowledge/skills.
- Responsible for completing required training within targeted timelines, initiating professional development and maintaining training records.
- Assists with training Clinical Studies Staff.
- Attends meetings and training sessions
Compliance & Due Diligence
- Conducts duties following established Apotex Inc., Biomedical Division Standard Operating Procedures, Departmental Practices and in a manner consistent with the appropriate regulator guidelines, GCP requirements and Safe Work Procedures.
- Assists in the creation, development and revision of Apotex Inc., Biomedical Divisions Clinical Operations Department Standard Operating Procedures and Departmental Practices.
- Completes all deviations exercises in a timely manner and implements appropriate corrective action to prevent reoccurrence
- Communicates compliance issues that arise with the volunteers/subjects
- Executes other duties as may be assigned by the Clinical Operations staff and/or delegates and as training and experience allow including but not limited to:
- Venipuncture through needle and/or indwelling catheter
- Performance Verification/Operation Verification
- Processing team leader, and venipuncture team leader
- Demonstrates corporate values and supports divisional objectives in the performance of work and in the interactions with others.
- Works as a member of a team to achieve all outcomes.
- Post secondary education in a Health Sciences or Related Discipline
- Previous experience in the laboratory setting
- Ability to multi-task
- Attention to detail
- Ability to work in a team environment
- Basic computer knowledge (i.e. Microsoft Word, Excel etc.)
- Flexibility to work day, evening and night shifts including weekends
- Good written and spoken English communication skills
- OSMT Certification would be an asset
- Venipuncture experience and demonstrated ability to perform venipuncture under time restraints is required in order to be able to perform blood draws in clinic and/or in screening
- Previous experience in performing 12 Lead Electrocardiograms would be an asset
- Previous experience working in a regulated environment and/or Clinical Research setting would be an asset
- 3 years ago
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