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 Accountabilities:
Key Job Responsibilities

1. Screening activities:

• 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

2. Pre-study support:

• Stocks screening and clinic supplies as needed
• Conducts Clinic/Screening set-up, and labelling

3. Pre-Study/In Clinic Activities:

• 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

4. Post study support:

• 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.

Decision Making/Autonomy

• 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

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
• 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.

Job Requirements/Education/Competencies:

• 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

Apotex - 7 months ago