Toronto, Ontario – Clinical Research Coordinator (CRC)

Position Reports To: Supervisor, Clinical Research

 

Position Summary:

  • Coordinates, executes and monitors all study activities to ensure conduct of clinical trials in accordance to study protocol, BPSI SOPs and/or Directives, ICH-GCPs and applicable regulatory guidelines
  • CRCA assists CRCs with Study related duties
  • Conducts protocol training for clinical research staff
  • Performs compliance check on subjects as applicable
  • Reports Adverse Events and Serious Adverse Events to appropriate department(s)
  • Supervises, administers and/or assists in a drug administration
  • Assists with dispensing, appropriate control, inventory, storage and record keeping of study drug(s) as required
  • Maintains study files for each clinical trial and performs detailed review of created and prepare by Study Preparation Associates subject and study source documentation and/or CRFs, as well as of completed Source Documents and CRFs
  • Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements
  • Ensures the accuracy of the generated data in accordance with protocols, ICH, GCP and applicable regulatory agencies
  • Maintains adequate, accurate, complete and legible records
  • Collaborates with QC and QA during audits and audit Follow-ups Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
  • Participate in staff training sessions
  • Performs other tasks as assigned and as training and experience allow

 

Qualifications:

  • Completed postsecondary degree in a science or healthcare related discipline, or equivalent work experience.
  • Certification in Clinical Research is an asset.
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements.
  • Human Abuse Liability Clinical Trial experience.
  • Excellent problem solving, communication, multitasking and interpersonal skills
  • Excellent in Microsoft Word and Excel.

Please send your resume to resumes@biopharmaservices.com 

Toronto, Ontario – Clinical Research Technician

Position Reports to: Senior Manager, Clinical Operations

 

Duties and Responsibilities: 

  • Review study protocol and participate in the protocol training meeting prior to performing any study related activities.
  • Perform ECG and vitals
  • Compliance check on subjects
  • Collect/process blood and urine samples as well as other specimens as required.
  • Perform drug/cotinine screen and alcohol test as well as urine pregnancy test.
  • Obtain body measurements including height and body weight, and calculate Body Mass Index (BMI).
  • Catheter insertion and removal
  • Proper collecting, handling and processing of PK samples
  • Process and ship lab samples
  • Assist in drug administration by performing hand and mouth check
  • Serve and/or monitor meals
  • Maintain accurate, complete, legible and timely data entry
  • Perform screening reception duties as required, including but not limited to ID verification, recording of Demographic information (Medical Screening staff only).
  • Perform data review of the source and/or other related documents as required.
  • Write and/or review source documentation forms
  • Conduct clinical staff training
  • Performs other tasks and projects as assigned

 

Qualifications:

  • 2 year Medical Technology Diploma, or equivalent
  • 1-2 years work experience in a CRO (preferably in conducting Phase I /Bioequivalence clinical trials)
  • 1-2 years of recent phlebotomy and ECG experience
  • A minimum of 1 year experience in a basic laboratory setting
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements

Please send your resume to resumes@biopharmaservices.com 

Toronto, Ontario – Clinical Assistant

Position Reports to: Sr. Manager, Clinical Operations

 

Duties and Responsibilities:

  • Assist with the set-up of the clinics
  • Label tubes
  • Perform subject sign in procedures
  • Perform bag search during check in and exit of a study
  • Escort subjects to the bathroom and monitor the bathroom activities as per protocol
  • Receive samples, count them and store them in a freezer as per protocol requirements
  • Assist with shipping of samples
  • Review study protocol and participate in the protocol training meeting prior to performing any study related activities.
  • Perform ECG
  • Collect urine samples as required.
  • Perform drug/cotinine screen and alcohol test as well as urine pregnancy test.
  • Assist in drug administration by performing hand and mouth check
  • Serve and/or monitor meals
  • Maintain accurate, complete, legible and timely data entry
  • Perform data review of the source and/or other related documents as required.
  • Data entry of Case Report Forms
  • Performs other tasks and projects as assigned

Qualifications:

  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements
  • Minimum High School Diploma

Please send your resume to resumes@biopharmaservices.com 

Toronto, Ontario – Registered Practical Nurse

Position Reports to: Sr. Manager, Clinical Operations

 

Duties and Responsibilities:

  • Perform ECG, Vital Signs, obtain blood sample and study specific testing
  • Obtain Medical History and Informed Consent from potential trial subjects
  • Obtain Informed Consent as appropriate
  • Explanation of the use of study drug(s)
  • Dispense and Administer study drug(s)
  • Receive physician’s medication order and administer medications from the crash cart
  • Adverse Event Reporting
  • Catheter insertion and removal
  • Perform drug/cotinine screen and alcohol test
  • Proper collecting, handling and processing of PK samples
  • Monitor and maintenance of Crash Cart
  • Cardiac Monitoring (Telemetry) (RN & Paramedic only)
  • Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
  • Maintain accurate, complete, legible and timely data entry
  • Write and/or review source documentation forms
  • Serve and/or monitor meals
  • Performs other tasks and projects as assigned

Qualifications:

  1. Education: RPN current registration with regulatory body in Ontario.
  2. Current BCLS & First Aid certification.
  3. Good interpersonal skills, good communication skills.
  4. Attentive to details, good initiative and able to work with changing priorities.
  5. Computer skills an asset.
  6. Ability to accommodate a flexible work schedule

Please send your resume to resumes@biopharmaservices.com