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:
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.
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