ABOUT OUR CLINIC
Alzheimer's disease (AD) is the most common type of dementia, making up approximately 70% of all cases. Those over the age of 65 are at a higher risk to develop AD. It diminishes cognitive, verbal and physical abilities by destroying brain cells. This in turn affects our ability to think, to learn new things, and to remember. Many scientific experts are working to ameliorate our understanding of this devastating disease, thus searching to find more effective treatments.
Our clinics partner with pharmaceutical companies to conduct Phase II and III clinical trials for Alzheimer's Disease. Our unique contribution will revolutionize the fight against the disease. We provide care to patients, generate knowledge for the scientific community, continue to improve support, and access to clinical research.
Understand the clinical trial work-flow:
Clinical Research: Clinical research is medical research that involves people to test new treatments and therapies.
Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Healthy Volunteer: A Healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.
Inclusion/Exclusion Criteria: Inclusion/Exclusion Criteria are factors that allow someone to participate in a clinical trial are inclusion criteria. Those that exclude or not allow participation are exclusion criteria.
Informed Consent: Informed consent explains risks and potential benefits about a clinical trial before someone decides whether to participate.
Patient Volunteer: A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition.
Phases of Clinical Trials: Clinical trials are conducted in “phases.” The trials at each phase have a different purpose and help researchers answer different questions.
- Phase I trials - An experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
- Phase II trials - The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
- Phase III trials - The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments.
- Phase IV trials - After a drug is licensed and approved by the FDA researchers track its safety, seeking more information about its risks, benefits, and optimal use.
Placebo: A placebo is a pill or liquid that looks like the new treatment but does not have any treatment value from active ingredients.
Protocol: A Protocol is a carefully designed plan to safeguard the participants’ health and answer specific research questions.
Principal Investigator: A Principal Investigator is a doctor who leads the clinical research team and, along with the other members of the research team, regularly monitors study participants’ health to determine the study’s safety and effectiveness.
Randomization: Randomization is the process by which two or more alternative treatments are assigned to volunteers by chance rather than by choice.
Single- or Double-Blind Studies
Single- or double-blind studies (also called single- or double-masked studies) are studies in which the participants do not know which medicine is being used, so they can describe what happens without bias. In single-blind ("single-masked") studies, you are not told what is being given, but the research team knows. In a double-blind study, neither you nor the research team are told what you are given; only the pharmacist knows. Members of the research team are not told which participants are receiving which treatment, in order to reduce bias. If medically necessary, however, it is always possible to find out which treatment you are receiving.
Types of Clinical Trials
- Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
- Natural history studies provide valuable information about how disease and health progress.
- Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning.
- Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.
- Screening trials test the best way to detect certain diseases or health conditions.
- Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Job Title: Principal Investigator (PI) – Clinical Trials
Location: Ottawa/Montreal
Position Type: Full-time, Permanent
Job Summary: We are seeking a highly skilled and experienced Principal Investigator (PI) to lead and oversee clinical trials within our organization. The PI will be responsible for ensuring the successful execution, oversight, and compliance of clinical studies in accordance with regulatory guidelines, ethical standards, and the scientific objectives of the research. This role requires a deep understanding of clinical trial methodologies, patient safety, data integrity, and regulatory requirements, as well as the ability to lead a multidisciplinary team and interact with stakeholders at all levels.
Key Responsibilities:
Leadership and Oversight:
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- Lead and manage Sponsors’ implementation, and execution of clinical trials from protocol development to study completion.
- Ensure all clinical trial activities are conducted in compliance with Good Clinical Practice (GCP), institutional guidelines, and regulatory requirements.
- Provide medical and scientific leadership and expertise throughout the trial process, ensuring scientific rigor and adherence to the research objectives.
Protocol Development and Study Design:
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- Collaborate with stakeholders (research teams, sponsors, regulatory bodies) to develop study protocols, case report forms (CRFs), and other essential study documents.
- Study and educate staff on protocol’s inclusion/exclusion criteria, endpoints, and other key components of the clinical trial design.
Patient Safety and Welfare:
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- Oversee the safety and well-being of study participants, ensuring appropriate monitoring and timely reporting of adverse events (AEs) and serious adverse events (SAEs).
- Ensure informed consent is obtained from all participants, and that participants' rights and confidentiality are protected throughout the study.
Regulatory Compliance and Documentation:
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- Ensure all necessary regulatory submissions are completed and approved in a timely manner (e.g., IRB/ethics committee approvals, IND/NDA submissions).
- Oversee accurate and complete data collection, source documentation, and timely reporting of study results in compliance with regulatory agencies (Health Canada, FDA, EMA, etc.).
Collaboration and Communication:
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- Serve as the primary point of contact for external stakeholders, including sponsors, regulatory agencies, and monitoring teams.
- Communicate regularly with the clinical trial team, including research coordinators, data managers, research assistants and other key personnel, to ensure smooth trial operations.
Training and Mentorship:
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- Provide ongoing education and guidance to clinical research staff, including clinical research associates (CRAs), coordinators, and other personnel.
- Mentor junior investigators and other staff, fostering a culture of professional development, ethical standards, and high-quality research.
Data Integrity and Reporting:
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- Ensure that clinical data is accurately recorded, and monitored in accordance with study protocols.
- Contribute to the preparation of clinical trial reports, manuscripts, and publications based on study findings.
Continuous Improvement:
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- Monitor and evaluate trial progress, ensuring any issues or obstacles are addressed in a timely manner.
- Identify opportunities for process improvements and contribute to the development of best practices within the clinical trial research environment.
Qualifications:
Education & Experience:
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- MD, PhD, NP, PharmD, or equivalent in a relevant scientific or medical discipline.
- Board certification in a relevant field (preferred).
- A minimum of 5-10 years of experience in clinical research, including experience as a PI in clinical trials.
- Experience with clinical trial design, GCP, and regulatory guidelines.
Skills & Competencies:
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- Strong knowledge of clinical trial design, GCP, FDA, ICH, and other applicable regulatory guidelines.
- Exceptional leadership, project management, and organizational skills.
- Ability to lead and manage multidisciplinary teams, prioritize tasks, and resolve conflicts.
- Excellent communication skills, both written and verbal, with the ability to effectively present data and findings.
- Proficiency with clinical trial management systems (CTMS), electronic data capture (EDC) systems (experience with CRIO is an asset, not a requirement), and other research-related tools.
Other Requirements:
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- Ability to work collaboratively and thrive in a fast-paced, dynamic research environment.
- Strong problem-solving and decision-making skills.
- Willingness to travel, if necessary, for site visits, monitoring, and meetings.
Preferred Qualifications:
- Experience in CNS specific therapeutic areas will be preferred.
Compensation and Benefits:
- Competitive salary, commensurate with experience.
- Comprehensive benefits package, including health, dental, vision, and RRSP match program.
- Opportunities for career development, continuing education, and professional growth.
