Principal Investigator

2 weeks ago

Toronto, Canada Headlands Research Full time

**Overview**:
**The Company**
- Toronto Memory Program, a Headlands Research site, is Canada’s largest and most experienced site for drug treatment trials in Alzheimer’s disease and related conditions. We have made significant contributions to over 140 drug treatment studies in Alzheimer’s disease since 1996. Our Medical Director, Dr. Sharon Cohen, a Canadian-trained behavioural neurologist, along with her team of highly trained research staff, have been committed to the development of better treatments for dementia since we were founded.**This new Clinical Research Physician (Principal Investigator) role will be based in Toronto, ON (North York), and is a full-time position.**

**Responsibilities**:
**Key Accountabilities**

**1. Physician Qualifications**:

- Possess experience in any of the following areas: neurology, geriatrics, family physician (care of elderly) or geriatric psychiatrist
- Maintain up-to-date curriculum vitae which reflects the requisite education, training and certifications to act as a clinical trial investigator
- Maintain current licensure to practice as an MD in Ontario another Canandian province
- Provide the sponsor and research ethics board (REB) with documentation of credentials as requested
- Disclose conflicts of interest
- Follow ICH-GCP, FDA CFR, Health Canada Division 5 guidelines, and TMP SOPs
- Work collaboratively with the entire research team
- Attend investigator meetings, site initiation meetings, and internal research meetings as assigned

**2. Ensure Protocol Compliance**:

- Possess a thorough understanding of the requirements of each clinical trial protocol
- Avoid protocol deviations or making any changes to protocol activities without agreement by the sponsor and prior review and approval by the REB (except to eliminate immediate hazard to the patient)

**3. Manage the Medical Care of the Research Subjects**:

- Possess familiarity with each clinical trial Investigator Brochure
- Assess patient compliance with protocol activities and study drug
- Evaluate and document adverse events
- Ensure provision of medical care and follow up as needed for adverse events
- Communicate in a timely manner with the medical monitor assigned by the sponsor to respond to and resolve any safety or eligibility concerns

**4. Protect the Rights and Welfare of Patients**
- Report all serious adverse events and adverse events of special interest to the sponsor within 24 hours and to the REB when the event meets the REB’s reporting requirements
- Obtain a signed and dated informed consent form from the patient or patient’s legally authorized representative (LAR) prior to initiating any study-related procedures
- Inform the patient and/or LAR about all aspects of the clinical trial
- Provide new information about the study or study drug as it becomes available

**5. Ensure Documentation of Study-Related Procedures, Processes and Events**:

- Document deviations from the approved protocol
- Cooperate with site PI in the development of corrective and preventative action plans (CAPAs) as needed
- Document the informed consent process
- Document all adverse experiences with respect to AE term, causality, seriousness, and management
- Comply with written procedures to document changes to data and/or case report forms

**6. Ensures the Proper Use and Storage of Investigational Product**:

- Be familiar with the use of the investigational product
- Be familiar with the Investigators Brochure, product insert, and other sources of information regarding the study drug

**7. Clinical Care**
- As part of recruitment initiatives and in conjunction with staff physicians, assess, diagnose and treat patients with neurological disorders.

**Qualifications**:
**Job Requirements**

**Competencies**:

- Strong communication skills
- Effective leadership skills
- Excellent interpersonal skills: Able to interact with professional, administrative staff, sponsor and regulatory representatives and patients

**Minimum Qualifications**:

- Minimum of one year experience as a Clinical Research Physician / Principal Investigator or minimum of three years of experience as a Sub-Investigator in clinical trials
- Thorough understanding of regulatory requirements
- Licensed, or eligible for license, to practice in the Province of Ontario
- At Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, our company is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans

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