Research Compliance
2 months ago
The Applied Health Research Centre (AHRC) of the Li Ka Shing Knowledge Institute is an Academic Research Organization (ARO) that provides clinical study project coordination and data management services to Investigators and sponsors at the University of Toronto and beyond. The AHRC supports and manages all aspects of the clinical research process including protocol development, study document development, clinical site management, clinical data management, data analysis and report writing. This position will offer the successful applicant a challenging and rewarding career in the clinical research area.
The primary role of the Research Compliance & Education Specialist is twofold:
- To plan, develop materials, and implement new services for academic researchers and institutions across Canada, focused on delivering clinical research training services
- To plan and conduct both on-site and remote clinical research monitoring activities. On-site visits to research study sites will require at least 50% travel both nationally and internationally. This position operates with limited supervision, with guidance from the Clinical Research Specialist and Manager, Research Quality and Process.
**DUTIES & RESPONSIBILITIES**:
**Monitoring**
- Plans and conducts both on-site and remote monitoring activities as defined in the protocol, ICH GCP, SOPs and Sponsor requirements
- Evaluates appropriateness of research sites to conduct the study, reviews and verifies site documents as required by protocol and ICH GCP
- Reviews accuracy, completeness and timeliness of completed study records, case report forms (CRFs), and other documents
- Documents monitoring activities in writing, using appropriate report formats, and promptly communicates deficiencies to appropriate stakeholders and takes necessary actions
- Identifies investigator misconduct and/or fraud. Presents findings to stakeholders
- Works cooperatively with clinical research staff and investigators to address their concerns and to communicate findings that can lead to improved clinical research study performance and/or compliance.
- Participates in meetings and training activities.
- Conducts assessments of potential Serious Adverse Events
- Reports Serious Adverse Events to regulatory agencies
- Works with sites to review barriers to recruitment, local site matters, and other related tasks
- Prepares study monitoring plans, monitoring reports and related documents.
- Communicates with sites, internal study team and study sponsor
- Other related research quality assurance duties as necessary
**Quality Planning, Control and Improvement**:
- Track and manage AHRC training files and processes
- Develops SOPs, tools and templates for research teams and institutions to facilitate efficient conduct of research
- Identify and disseminate best practices and facilitate quality improvement initiatives within research teams and institutions
- Support research teams and institutions in preparing for external audits
**Knowledge Building and Fostering Collaborative Partnerships**:
- Initiate and maintain collaborative relationships with key individuals and departments to ensure a research team / institution wide approach to research quality
- Plan, implement and deliver education sessions related to research conduct and quality management
- Act as a resource in interpreting regulatory, privacy and research guidance documents
- Identifies and promotes internal and external sources of research expertise and education
**QUALIFICATIONS**:
- Minimum educational requirement of a bachelor’s degree in a health related or life sciences field, or demonstrable equivalent combination of specialized education and experience
- Certified Clinical Research Professional (CCRP) certification an asset
- Requires ability to travel nationally, to the USA and to international destinations
- Strong knowledge of ICH/GCP and Canadian/US regulatory requirements
- 2 years + experience of on-site and remote monitoring of clinical research sites
- Demonstrated initiative, willingness to learn
- Excellent interpersonal, verbal and writing skills
- Ability to work independently and under pressure with tight deadlines
- Experience with MS Office Suite (Excel, PowerPoint, Word, Outlook)
- Ability to independently author monitoring reports, monitoring plans and other quality assurance documents
**_
-
Clinical Research Coordinator
1 month ago
Toronto, Canada Headlands Research Full timeOverview: **The Role** Toronto Memory Program is looking for a Clinical Research Coordinator to manage clinical research protocols. This individual will work directly with the investigators, and other research staff to ensure protocol visits are being conducted according to ICH GCP guidelines. **This Clinical Research Coordinator role will be based in...
-
Clinical Research Coordinator
1 month ago
Toronto, Canada Headlands Research Full timeOverview: - 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. Founded in 1996, we have made significant contributions to over 100 drug treatment studies in Alzheimer’s disease. Our Medical Director, Dr. Sharon Cohen, a...
-
Clinical Research Coordinator
4 weeks ago
Toronto, Canada Headlands Research Full time**Overview**: - 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. Founded in 1996, we have made significant contributions to over 100 drug treatment studies in Alzheimer’s disease. Our Medical Director, Dr. Sharon Cohen, a...
-
Clinical Research Coordinator
4 weeks ago
Toronto, Canada Headlands Research Full timeOverview: - 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. Founded in 1996, we have made significant contributions to over 100 drug treatment studies in Alzheimer’s disease. Our Medical Director, Dr. Sharon Cohen, a...
-
Research Associate
1 month ago
Toronto, Canada Lunenfeld-Tanenbaum Research Institute Full time**Reference Number**:000001892 **Posted Date**:11/13/2023 **Closing Date**:11/24/2023 **Department**:LTRI (Healthy Ageing and Geriatrics Program) **Position**:Research Associate **POSITION TITLE** - Research Associate**DEPARTMENT** - LTRI (Healthy Ageing and Geriatrics Program)**EMPLOYMENT TYPE** - Temporary, Part-Time**HOURS OF WORK** - 7.5 to 24 hours...
-
Research Assistant I
1 week ago
Toronto, Canada Lunenfeld-Tanenbaum Research Institute Full time**Reference Number**:000001861 **Posted Date**:8/24/2023 **Closing Date**:9/14/2023 **Department**:LTRI - Leadership Sinai Centre for Diabetes **Position**:Research Assistant I **POSITION TITLE** - Research Assistant I**DEPARTMENT** - LTRI - Leadership Sinai Centre for Diabetes**EMPLOYMENT TYPE** - Temporary, Full-Time**HOURS OF WORK** - 37.5 hours per...
-
Research Ethics Officer
2 hours ago
Toronto, Canada Ontario Institute for Cancer Research Full time**Position: Research Ethics Officer** **Location: MaRS Centre, Toronto** **Department: Ontario Cancer Research Ethics Board (OCREB)** **Reports To: Executive Director, OCREB** **Salary: Commensurate with level of experience** **Hours: 35 hours/week** **Job Type: Hybrid** **Status: Full-time, Permanent** The Ontario Cancer Research Ethics Board (OCREB) is a...
-
Toronto, Canada Exiger Full time**Job Location**: Remote Exiger Diligence is excited to welcome to its team experienced due diligence, compliance, and risk research professionals. We are searching for talented research professionals who know this industry and are passionate about research. We are also pleased to be expanding the geographic reach of our team by seeking professionals based...
-
Research Assistant Ii
1 month ago
Toronto, Canada Lunenfeld-Tanenbaum Research Institute Full time**Reference Number**:000001812 **Posted Date**:4/25/2023 **Closing Date**:5/9/2023 **Department**:LTRI (Neonatal Hemodynamics Research Program) **Position**:Research Assistant II **POSITION TITLE** - Research Assistant II**DEPARTMENT** - LTRI (Neonatal Hemodynamics Research Program)**EMPLOYMENT TYPE** - Temporary, Full-Time or Temporary, Part-Time**HOURS...
-
Research Assistant Ii
1 month ago
Toronto, Canada Lunenfeld-Tanenbaum Research Institute Full time**Reference Number**:000001927 **Posted Date**:2/29/2024 **Closing Date**:3/21/2024 **Department**:LTRI (Neonatal Hemodynamics Research Program) **Position**:Research Assistant II **POSITION TITLE** - Research Assistant II**DEPARTMENT** - LTRI (Neonatal Hemodynamics Research Program)**EMPLOYMENT TYPE** - Temporary, Part-Time**HOURS OF WORK** - 7.5 to 24...
-
Research Assistant I
1 week ago
Toronto, Canada Lunenfeld-Tanenbaum Research Institute Full time**Reference Number**:000001957 **Posted Date**:5/1/2024 **Closing Date**:5/15/2024 **Department**:LTRI - Infectious Diseases Epidemiology Research Unit **Position**:Research Assistant I **POSITION TITLE** - Research Assistant I**DEPARTMENT** - LTRI (Infectious Diseases Epidemiology Research Unit)**EMPLOYMENT TYPE** - Temporary, Part-Time**HOURS OF WORK** -...
-
Research Assistant Ii
19 hours ago
Toronto, Canada Lunenfeld-Tanenbaum Research Institute Full time**Reference Number**:000001944 **Posted Date**:4/11/2024 **Closing Date**:5/2/2024 **Department**:LTRI **Position**:Research Assistant II **POSITION TITLE** - Research Assistant II**DEPARTMENT** - LTRI**EMPLOYMENT TYPE** - Temporary, Full-Time**HOURS OF WORK** - 30 hours weekly (4 days a week)**EMPLOYEE GROUP** - Non-Union**REPORTS TO** - Principal...
-
Clinical Research Associate
1 month ago
Toronto, Canada Allphase Clinical Research Inc. Full time**Job Title**: Clinical Research Associate **Date**: November, 13, 2023 **Location**: Toronto, ON **Remote**: Yes **Business Unit**: Health **Department**: CRO Calian is seeking an experienced Clinical Research Associate (CRA) in the Toronto area for an exciting opportunity to work within our dynamic team. The CRA will act as the primary contact with...
-
Toronto, Canada Think Research Full time**The Company** BioPharma Services Inc. is a subsidiary of Think Research. BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma. Through each success, and even some failures, the...
-
Toronto, Ontario, Canada OICR Full timeSalary: Commensurate with level of experienceAbout UsThe Ontario Institute for Cancer Research (OICR) is Ontario's cancer research institute. We bring together people from across the province and around the world to improve the lives of everyone affected by cancer. We take on the biggest challenges in cancer research and deliver real-world solutions to find...
-
Toronto, Ontario, Canada OICR Full timeSalary: Commensurate with level of experienceAbout UsThe Ontario Institute for Cancer Research (OICR) is Ontario's cancer research institute. We bring together people from across the province and around the world to improve the lives of everyone affected by cancer. We take on the biggest challenges in cancer research and deliver real-world solutions to find...
-
Research Specialist
2 months ago
Toronto, Canada Info-Tech Research Group International Full time**Location**: Hybrid (Toronto, ON or London, ON, combined with work from home) **Who are we**: Come join us as we are expanding our Research Team! Info-Tech is one of the world’s fastest-growing IT research and advisory companies, proudly serving over 40,000 IT professionals. We produce unbiased and highly relevant IT research to help CIOs and IT leaders...
-
Senior Clinical Research Associate
2 weeks ago
Toronto, Canada Everest Clinical Research Services Inc Full timeEverest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical...
-
Senior Clinical Research Associate
2 days ago
Toronto, Canada Everest Clinical Research Services Inc Full timeEverest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical...
-
Project Manager, Clinical Research
2 weeks ago
Toronto, Canada Lunenfeld-Tanenbaum Research Institute Full time**Reference Number**:000001949 **Posted Date**:4/22/2024 **Closing Date**:5/24/2024 **Department**:LTRI **Position**:Project Manager, Clinical Research **POSITION TITLE** - Project Manager, Clinical Research**DEPARTMENT** - LTRI**EMPLOYMENT TYPE** - Regular Full Time**HOURS OF WORK** - 37.5 hours per week**EMPLOYEE GROUP** - Non-Union**REPORTS TO** -...
