Toronto, Ontario – Project Manager

Reports to:  Director Project Management

 

Position Summary:

To oversee all associated activities related to a Phase I/BE study program from inception (i.e. Study award) to completion (i.e. issuance of final report).  Maintain awareness of overall study requirements in accordance with finalized protocol and ensure this is adhered to in all projects managed under your responsibility.

 

General Responsibilities:

  • Maintain a tracking process for the studies managed; including initiation, tracking, timelines reporting, budgeting and report writing
  • Within scope of position, provide sound scientific advice to clients either directly or via other BPSI staff; co-ordinate teleconferences with appropriate personnel, address client questions, concerns or comments
  • Negotiate client’s milestones and assist staff as required
  • Use appropriate communication tools to update clients on the status of their project(s); should there be any deviation, immediately handle them appropriately and if required notify Manager, Project Management and/or Operations
  • Actively participate in the weekly tracking meeting making sure you are current with the most current information from operations and provide any new client information
  • Create and develop quotations for review by DPM and receive appropriate signatures as required
  • Follow up with existing accounts on new business opportunities and manage activities around outstanding quotations, Confidentiality Agreements, Contracts etc.
  • Whenever appropriate, maintain awareness and provide input on study designs and protocols
  • Assist in the preparation and maintenance of all departmental reports and all tracking databases; ensure that they are updated accurately and issued in a timeline fashion (includes quotation and contract templates, weekly tracking reports, financial reports etc.)
  • Ensure appropriate documents have been reviewed and circulated within BPSI prior to providing to clients
  • If required, assist in promotion of BPSI at industry meetings and trade shows
  • Maintain a good understanding of regulatory guidelines (TPD, FDA, EMEA, MHRA, ICH, TGA, ANVISA) and understanding of basic pharmacokinetics and statistics
  • Assist finance department in developing transfer of pertinent financial information

 

Qualifications:

  • Bachelor of Science (B.Sc.) degree or equivalent
  • Relevant background in the healthcare, pharmaceutical industry
  • Minimum of 2 years experience in a project management role in either Phase I/BE or Phase I – IV setting
  • Familiarity with the management of all phase I/BE
  • Demonstrated experience dealing with a wide variety of project stakeholders at all levels in and across various organizational departments
  • Excellent interpersonal, communication and presentation skills
  • Strong organization, prioritization and problem solving skills
  • Ability to manage and handle several projects simultaneously

Highly proficient in MS Office Suite (Word, Excel, PowerPoint, MS Project)

 

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