Sub Investigator

Pharma Medica Research Inc.; Toronto; On-site; CAD 100,000 - 180,000; Full time

Job summary

Pharma Medica Research Inc. (PMRI) is seeking a Sub Investigator on an as-needed basis in Ontario to oversee subject safety in Phase I trials, ensuring GCP compliance and adherence to SOPs. Reporting to the Principal Investigator, you may serve as Investigator as needed and work onsite with trial staff.

Requirements include valid medical license in Ontario, 3–5 years Phase I experience, and strong English communication. PMRI is an Equal Opportunity Employer and supports accessibility.

Qualifications

• Valid medical license in Ontario.
• Related experience within a Phase I clinical center desired.
• 3-5 years of related experience.
• Excellent knowledge of GCP (ICH, Health Canada, FDA), related regulatory requirements, PMRI SOPs.
• Excellent understanding of Phase I study documentation.
• Excellent communication skills including excellent English verbal and written skills.
• Ability to communicate clearly and effectively with other clinical staff.
• Excellent interpersonal skills.
• Ability to work both independently and as a team member.
• Strong proficiency in computer usage and software applications.

Responsibilities

• Responsible for the protection of the rights, safety and welfare of subjects.
• Responsible for the medical care of trial subjects.
• Be thoroughly familiar with the use of the investigational product as described in the investigational brochure (if any), the protocol, and any other information sources.
• Comply with PMRI’s standard operating procedures (SOPs), Good Clinical Practices (GCP) and any other applicable regulatory requirements.
• Adhere to the protocol agreed upon in advance by the sponsor and the IRB.
• Follow the trial’s randomization procedures, if any, and ensure that the code is broken only in accordance with the protocol or if medically necessary.
• Be present during drug administration and be available onsite for the first four (4) hours post-drug administration after the first subject has been dosed, or as specified by the protocol; remain on-call until the end of the study.
• Sign applicable regulatory documents.
• Ensure ICFs are provided and explained to the subjects; review and sign ICFs.
• Document/approve medically related deviation(s) to the protocol.
• Ensure the correct use of investigational products is explained to the subjects.
• Review laboratory results, vital signs, ECG.
• Conduct physical examinations, both pre and post study.
• Determine subject participation eligibility.
• Subject safety monitoring, adverse event documentation and medical treatment.
• On call for medical emergency.
• Review and assess adverse event(s).
• Terminate subject’s participation due to subject safety reasons.
• Terminate the study due to subject safety reasons.
• Review and sign study related documents (i.e., protocol, protocol amendments as required, FDA Form 1572, QIU, financial disclosure, final study report) if applicable and/or required.
• Interact with the IRB to explain and/or discuss medical issues regarding specific study protocols, if applicable and/or required.
• Attend site initiation training or protocol training upon request.
• Other related duties as required or delegated by the Principal Investigator.

Skills

Medical license (Ontario)

Phase I experience

GCP knowledge

Clinical communication

Independent work

Team collaboration

Job description

Pharma Medica Research (PMRI) Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding. At PMRI we are committed to making a difference in healthcare and people’s lives.

Come join our team! We are currently looking for a consultant to join our team as a Sub Investigator on an as needed basis.

This position is responsible for the safety and well-being of all subjects participating in Phase 1 Clinical Trials, ensuring compliance with Good Clinical Practice (GCP) and related regulatory requirements, Standard Operating Procedures (SOPs), and protocols at Pharma Medica Research Inc. (PMRI). This position reports to the Principal Investigator. May act as Investigator for trials as needed.

Responsibilities

• Responsible for the protection of the rights, safety and welfare of subjects.
• Responsible for the medical care of trial subjects.
• Be thoroughly familiar with the use of the investigational product as described in the investigational brochure (if any), the protocol, and any other information sources.
• Comply with PMRI’s standard operating procedures (SOPs), Good Clinical Practices (GCP) and any other applicable regulatory requirements.
• Adhere to the protocol agreed upon in advance by the sponsor and the IRB.
• Follow the trial’s randomization procedures, if any, and ensure that the code is broken only in accordance with the protocol or if medically necessary.
• Be present during drug administration and be available onsite for the first four (4) hours post-drug administration after the first subject has been dosed, or as specified by the protocol; remain on-call until the end of the study.

Responsibilities if delegated by the Investigator as per SOP CLN220 Investigator’s Responsibilities

• Sign applicable regulatory documents.
• Ensure ICFs are provided and explained to the subjects; review and sign ICFs.
• Document/approve medically related deviation(s) to the protocol.
• Ensure the correct use of investigational products is explained to the subjects.
• Review laboratory results, vital signs, ECG.
• Conduct physical examinations, both pre and post study.
• Determine subject participation eligibility.
• Subject safety monitoring, adverse event documentation and medical treatment.
• On call for medical emergency.
• Review and assess adverse event(s).
• Terminate subject’s participation due to subject safety reasons.
• Terminate the study due to subject safety reasons.
• Review and sign study related documents (i.e., protocol, protocol amendments as required, FDA Form 1572, QIU, financial disclosure, final study report) if applicable and/or required.
• Interact with the IRB to explain and/or discuss medical issues regarding specific study protocols, if applicable and/or required.
• Attend site initiation training or protocol training upon request.
• Other related duties as required or delegated by the Principal Investigator.

Qualifications

• Valid medical license in Ontario.
• Related experience within a Phase I clinical center desired.
• 3-5 years of related experience.
• Excellent knowledge of GCP (ICH, Health Canada, FDA), related regulatory requirements, PMRI SOPs.
• Excellent understanding of Phase I study documentation.
• Excellent communication skills including excellent English verbal and written skills.
• Ability to communicate clearly and effectively with other clinical staff.
• Excellent interpersonal skills.
• Ability to work both independently and as a team member.
• Strong proficiency in computer usage and software applications.

Please note all applications must be eligible to work within Canada.

PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.

We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.