Clinical Investigator (MD) at Altasciences
Montréal, QC, Canada -
Full Time


Start Date

Immediate

Expiry Date

09 Oct, 25

Salary

0.0

Posted On

09 Jul, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Working Environment, English, Regulatory Agencies

Industry

Pharmaceuticals

Description

YOUR NEW COMPANY!

At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. Â No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.
We are better together and together We Are Altasciences.

Responsibilities

ABOUT THE ROLE

The Clinical Investigator (MD) is responsible for overseeing and delegating tasks related to the clinical trial under their leadership. The Clinical Investigator (MD) ensures the trial is conducted in accordance with Good Clinical Practice (GCP) by adhering to the study protocol, protecting participant rights and welfare, maintaining data integrity, and ensuring compliance with all applicable regulations, guidelines, and standard operating procedures (SOPs).

WHAT YOU’LL DO HERE

  • Oversee all clinical activities related to the clinical trials for which they serve as Principal Investigator.
  • Ensure subject eligibility is met based on protocol inclusionary/exclusionary criteria and that the subject continues to meet eligibility criteria throughout the course of a clinical trial.
  • Perform physical examinations and medical history intake and review.
  • Ensure subject safety at all times, this may include but is not limited to: review of clinical laboratory results and/or other test results. Review and/or performance of vital signs, ECGs or other safety tests.
  • Record and follow-up on adverse events and determine causality.
  • Report serious adverse events to appropriate parties.
  • Be on-site for surveillance as required by protocol and remain available on-call for medical events.
  • Perform critical trial related tasks and/or make trial related decisions during the course of the trial.
  • Delegation of trial related tasks and the review of employees on the Delegation of Authority and Signature Log per job title/training record.
  • Perform protocol training.
  • Provide documentation for the Sub-Investigators.
  • Ensure requirements related to obtaining informed consent are met.
  • Participate in sponsor visits and regulatory audits.
  • Document study related events incompliance with GCP.
  • Complete and/or review regulatory documents as applicable.
  • Review study protocols and SOPs.
  • May act as Sub-Investigator on studies not assigned to them as Principal Investigator.
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