Location: 603-7 St Thomas St., Toronto, ON
The Sub Investigator works closely with the Principal Investigator to oversee the execution of study protocols, delegating study-related duties to site staff, as appropriate, and ensuring site compliance with study protocols, study-specific laboratory procedures, standards of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), quality (QA/QC) procedures, safety guidelines, and other regulations as applicable. He/She will also oversee a clinical operations staff of roughly 4-5 people.
This position is considered essential (by COVID-19 government regulations) and has a substantial clinical presence requirement. Clinic presence could start as early as 6:30 – 7 am on certain pre-scheduled days. Weekends (mainly Saturdays, scheduled in advance) may also be required for certain studies. Also, only candidates with a professional medical degree, like an MD (or verified international equivalent) should apply. Provincial CPSO licence is an asset, but not required. We are looking for someone who can start immediately.
- Performs the duties of Investigator, as delegated by the Principal Investigator, for clinical research trials, typical examples include, but not limited to: a routine review of participant medical history and concomitant medications, clinical chemistry and laboratory results for safety and eligibility, physical examination, and/or other clinical assessments as well as investigational product dispensing/accountability as delegated by the site PI.
- Performs duties in accordance with the highest standard of ICH-GCP, Health Canada, and FDA compliance, as applicable, consistently upholding participant safety, protocol compliance, and research site/clinic operations.
- Reviews and interprets clinical analyses including, but not limited to: laboratory results, medical history, concomitant medications & treatments, and any other analyses and/or assessments defined by the protocol and delegated to the Sub-Investigator by the PI.
- Reviews medical histories and performs basic physical examinations of potential and enrolled study participants to evaluate eligibility and/or conduct ongoing study assessments as per protocol, SOP’s and best practice; seeking routine, documented approval and guidance from the Principal Investigator
- Maintains a strong, efficient and professional liaison between the research site and the Principal Investigator; supporting the PI in all aspects including the preparation of all items requiring PI review or signature, and coordination of PI- on-site and remote involvement in collaboration with Director Clinical Research and other research team members as needed.
- Oversees auxiliary tasks delegated to research site staff and maintains applicable delegation logs and pertinent ISF documents in collaboration with Clinical Research Associates, Clinical Research Regulatory Affairs Associates, and other research team members as needed.
- Supports the Director Clinical Research with regards to clinical operations, and implements any applicable and ongoing training of clinical staff, on a per-protocol basis, to ensure protocol integrity throughout the trial lifecycle
- Maintains thorough familiarity with responsibilities of an Investigator, Sponsor, and Site as per ICH-GCP, Health Canada, and FDA Guidelines/Regulations.
- Serves as medical consultant in the new project feasibility phase, quoting process, and protocol design (internal and sponsor – provided)
- Functions as an integral member of the site team offering medical and protocol-specific guidance
- Ensure compliance with applicable research site SOP’s
- Execute other duties as may be required by the site (e.g., assist with difficult phlebotomy
- M.D. (international education will be considered)
- Post-Graduate Certificate in Clinical Research, preferred
- IHC-GCP Certification, preferred
- Previous experience in a clinical research environment in a Sub-Investigator or related role
- Proficient in standard venipuncture/phlebotomy
- Proficient in the review of laboratory analyses for safety and eligibility
- Broad knowledge of general medicine with preferred interest in natural health products/research of same
- Current CPR / Advanced Cardiac Life Support (ACLS) certification
- Ability to apply critical thinking to make informed decisions with a focus on participant well-being and data quality
- Ability to communicate effectively, orally, and in writing to stakeholders, site staff, and participants
- Proficient in reading, writing, and mathematical operations
- Proficient in MS Office as well as communication tools (Outlook etc.) and clinic management databases / CTMS platforms and EDC systems.
In addition, we value the following qualities in our team members:
- Personality characterized by high-quality standards, responsibility, and engagement
- Ability to interact with a range of personalities and many levels of the organization
- Demonstrated self-motivation and the ability to take initiative
- Project management and strong prioritization skills
- Attention to and ability to execute details
- Adaptable to changing environment, client, and project needs