34 Medical Researchers jobs in Toronto

Job Description

Company Description

PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

• Coordinates investigator/ site feasibility and identification process, as well as study startup.
• Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
• Manages Monitors in the query resolution process, including Central Monitoring observations.
• Coordinates safety information flow and protocol/process deviation reporting.
• Performs clinical supplies management with vendors on a country and regional level.
• Ensures study-specific and corporate tracking systems are updated in a timely manner.
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
• Coordinates planning of supervised monitoring visits and conducts the visits. 
• Manages the project team in site contracting and payments.
• Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
• Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
• Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
• Oversees project team in CAPA development and implementation.
• Coordinates project team in process deviations review, management and reporting.
• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
• Delivers trainings and presentations at Investigator Meetings.
• Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
• Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
• Ensures data integrity and compliance at a site level.
• Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
• Conducts project-specific training of site Investigators.
• Supports preparation of draft regulatory and ethics committee submission packages.

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
• Minimum of 5 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor. 
• Must have prior experience monitoring or managing sites and CRAs in the United States with knowledge of US regulatory guidelines and practices. 
• Experience with all types of monitoring visits in Phases I-III. 
• Strong experience in Oncology preferred.
• Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. 
• Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. 
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to plan, multitask and work in a dynamic team environment.
• Excellent Communication, collaboration, and problem-solving skills.
• Ability to travel up to 65% (depending on project needs).
• Valid driver’s license (if applicable).

All your information will be kept confidential according to EEO guidelines.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Summary

The Registered Dietitian is a per diem/PRN position for PCM Trials. A PCM Trials RD will provide nutritional services defined in a clinical trial virtually or in-person for clinical trial participants.

• Perform the full scope of Registered Dietitian practices; including, but not limited to, providing virtual lifestyle counseling visits to improve nutrition and dietary quality, mental health and developing coping skills, and building health behavior and lifestyle habits that align with participant’s goals and values.
• Work cooperatively with Clinical Project Managers, Coordinators, and site personnel to complete visits and submit accurate source documentation.
• Sets appointments with subjects within the required appointment window.
• Completes virtual visits for clinical trial subjects.
• Maintains all necessary licenses, certifications, credentialing materials and other required documents.
• Regularly stay informed on the latest nutrition and food health updates.
• Performs additional duties and responsibilities as deemed necessary.

Required Qualifications

• University degree in human nutrition and dietetics from an approved program.
• Current Dietitian Registration with a Province/Territory (if applicable)

Preferred Qualifications

• One (1) year of recent practice performing the full scope of a Registered Dietitian such as providing lifestyle counseling to improve nutrition, dietary quality, mental health, and development of coping skills.

Personal Incentives

• Gain CMRD GCP training certification
• Be a member of our general staffing pool
• No research experience required, on the job training provided
• Contribute to advancements of truly life changing treatments

Professional Case Management is an Equal Opportunity Employer.

As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Oversee multiple oncology trials, ensuring high-quality execution
• Provide leadership and mentorship to junior flex team members
• Act as Lead SM, training and guiding other Site Managers on study protocols
• Develop essential study start-up documents, including SIV agendas
• Represent Site Managers and Lead Trial Managers (LTMs) in key meetings
• Ensure the SM perspective is reflected in study documents like Monitoring Guidelines
• Review reports (SQV, SMV, SCV) for sites assigned to other SMs within the same trial
• Support country budget development and contract negotiations in collaboration with CCS colleagues
• Assist with ASV activities and ensure alignment with study objectives
• Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)

You Are:

• Remote position located in Toronto, Canada
• Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
• At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
• Knowledge of several therapeutic areas is an asset, including oncology – preferably Hematology, Prostate Cancer, Lung Cancer, Early development (Phase 1) etc.
• Knowledge of risk-based/analytical monitoring approaches is an asset
• Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
• Ability to actively drive patient recruitment strategies at assigned sites
• Strong collaboration with investigators and site staff to meet study timelines
• Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
• Ability to work independently while being a strong collaborator
• In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
• Up to 50% regional travel required
• To qualify, applicants must be legally authorized to work in Canada, and should not require, now or in the future, sponsorship for employment visa status

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON:

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Oversee multiple oncology trials, ensuring high-quality execution
• Provide leadership and mentorship to junior flex team members
• Act as Lead SM, training and guiding other Site Managers on study protocols
• Develop essential study start-up documents, including SIV agendas
• Represent Site Managers and Lead Trial Managers (LTMs) in key meetings
• Ensure the SM perspective is reflected in study documents like Monitoring Guidelines
• Review reports (SQV, SMV, SCV) for sites assigned to other SMs within the same trial
• Support country budget development and contract negotiations in collaboration with CCS colleagues
• Assist with ASV activities and ensure alignment with study objectives
• Maintain compliance with Metrics/KPIs as outlined in the Quality Oversight Plan (QOP)

You Are:

• Remote position located in Toronto, Canada
• Minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
• At least 2 years of experience monitoring clinical trials in the pharmaceutical industry
• Knowledge of several therapeutic areas is an asset, including oncology – preferably Hematology, Prostate Cancer, Lung Cancer, Early development (Phase 1) etc.
• Knowledge of risk-based/analytical monitoring approaches is an asset
• Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools
• Ability to actively drive patient recruitment strategies at assigned sites
• Strong collaboration with investigators and site staff to meet study timelines
• Effective communication and influencing skills to manage study sites effectively, both remotely and in-person
• Ability to work independently while being a strong collaborator
• In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements
• Up to 50% regional travel required
• To qualify, applicants must be legally authorized to work in Canada, and should not require, now or in the future, sponsorship for employment visa status

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON:

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.