- 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.
What You'll Need to Succeed Required to have an active medical license from the Collège des médecins du Québec - Required to have a current ACLS certification card.
- Excellent communication skills in French and English.
- Previous experience with similar responsibilities; ideally related to the industry an asset.
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Clinical Investigator - Montreal - Altasciences Co.
Description
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Clinical Investigator (MD) page is loaded## Clinical Investigator (MD)remote type: On-sitelocations: Montreal, Quebectime type: Full timeposted on: Posted 2 Days Agojob requisition id: R101673
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.
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.
About The RoleThe Clinical Investigator (MD) is responsible for overseeing and delegating tasks related to the clinical trial under their leadership.
What You'll Do Here Oversee all clinical activities related to the clinical trials for which they serve as Principal Investigator.
Fluency in English is an essential requirement for the position of Clinical Investigator (MD)including, but not limited to, for the following reasons:* The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCHAltasciences is an equal opportunity employer committed to diversity and inclusion.
Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives.
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation.
Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences#J-18808-Ljbffr
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