Algorithme Pharma Doctor (Internal Sub-Investigator) Temporary in Montréal, QC

Algorithme Pharma

Branch Montréal QC CA

Doctor (Internal Sub-Investigator)
Montréal, QC

Arrive at the site before drug administration in order to evaluate the eligibility of the subject for the dosing when assigned to the surveillance of the…

The Internal Sub-Investigator (Clinician) is responsible for supervising the medical team involved in a screening session or in a clinical trial session, to which they has been assigned by the Clinical Investigator. The Internal Sub-Investigator (Clinician) ensures that an effort is made at all times to ensure the volunteer’s safety. They will perform the following responsibilities: -Fulfill the tasks delegated by the clinical investigator. – Perform critical trial related procedures and/or to make important trial-related decisions during the course of a trial.

  • Sign any applicable regulatory Statement of Investigator, Financial Disclosure or else. – Ensure that the research project is conducted according to the protocol and applicable regulations, the GCPs and SOPs. – Ensure that the protocol inclusion/exclusion criteria are respected in order to assign a volunteer as a subject to a research project. – Perform an adequate physical examination, complete the medical history and complete the inclusion /exclusion criteria section if applicable.
  • Verify all the information available in the screening record (nurses notes, medical history already on file, vital signs, ECG, etc.) and up-date the subjects medical history. – Inform immediately the screening team if a volunteer is rejected, to prevent further and unnecessary examinations or tests to be performed. – Explain and sign with the volunteer, the informed consent form, or assist staff specifically trained for handling the consent process, ensuring that the volunteer understands perfectly the stakes of participating in the research project. – Comply with GCPs and Algorithme Pharma SOPs requirements and to get adequately acquainted with the protocol and investigational product to be tested on the research projects they are involved with.
  • Arrive at the site before drug administration in order to evaluate the eligibility of the subject for the dosing when assigned to the surveillance of the subject’s health status after a dosing. – Stay on site for the period of time required by the protocol and to remain available on-call for any medical events occurring during the rest of the period of the trial. – Decide of the actions to be taken and to document adequately when a clinical event, significant or not, severe or not, occurs under his surveillance. Desired profile: – Physician enrolled on the Collège des médecins du Québec.
  • Ph.D. in Medicine. – Bilingual (French and English). – 1 to 2 years of practical experience.
  • Experience in Clinical research, is an asset. – Knowledge of any applicable regulations pertaining to safety, ethical issues and clinical assessments when dealing with clinical research and human volunteers and, knowledge of federal and provincial regulations regarding medical act and nursing care are required. Skills: – Ability to adapt to changing priorities. – Highly developed organizational and time management skills.
  • Software: MS-Office.

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Employment Type: Temporary
Location: Montreal, QC, CA
Posted on: 2015-07-31
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