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Clinical Operations Technician

APOTEX INC.

North York, ON, CANADA | GTA, ON, CANADA
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About Apotex:

 

Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!


We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds.

 
We’d love to hear how you could contribute to the team!

 

 

Job Summary:

 

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.


Job Responsibilities:

 

Key Job Responsibilities

 

1. Screening activities:
• Performs 12 lead Electrocardiograms (ECGS), vital signs and Height/Weight
• Obtains and 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

2. Pre-study support:
• Stocks screening and clinic supplies as needed
• Conducts Clinic/ Screening set-up, and labeling

3. Pre-Study/In Clinic Activities:
• Is prompt and reliable and is adequately prepared to perform assigned activities
• Conducts 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

4. Post study support:
• Performs Waste Management of the chemical and biohazard waste
• Conducts sample sorting and sample transfer

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.

Decision Making/Autonomy
• Prioritizes responsibilities in such a manner that allows all screening/clinical events to occur in a timely manner
• Receives direction and instructions from on-duty clinic personnel (CRC/COC/CRA/Clinic Management)

 

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 other Clinical Operations Technicians as needed
• Attends meetings and training sessions

 

Compliance & Due Diligence

 

• Conducts duties following established Apotex Inc., AGO – BioClinical Development Standard Operating Procedures, and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures
• Adeheres to corporate policies and applicable corporate Standard Operating Procedures
• Assists in the creation, development and revision of Clinical Operations Department Standard Operating Procedures
• 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

 

Other:

 

• 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

• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence
• Works as a member of a team to achieve all outcomes
Performs all work in accordance with all established regulatory and compliance and safety requirements


Job Requirements:

 

• 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
• 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
• OSMT Certification would be an asset

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

 

 

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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