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 Prospect 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.

📌 Sub Investigator (Toronto)
🏢 Pharma Medica Research
📍 Toronto