Clinical Research Project Manager, ONLOOP
Top Benefits
About the role
Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) is one of the largest and most respected paediatric healthcare centres in the world. As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading-edge research and education. Our reputation would not have been built - nor could it be maintained - without the skills, knowledge and experience of the extraordinary people who come to work here every day. SickKids is committed to ongoing learning and development, and features a caring and supportive work environment that combines exceptionally high standards of practice.
When you join SickKids, you become part of our community. We share a commitment and determination to fulfill our vision of Healthier Children. A Better World .
Don't miss out on the opportunity to work alongside the world's best in paediatric healthcare.
Clinical Research Project Manager The Clinical Research Project Manager works closely with the Principal Investigators to plan and manage the overall research program and the research team. ONLOOP is a research program that helps adult survivors of childhood cancer in Ontario monitor for late effects from their cancer treatment. Responsibilities include long-term planning and day-to-day operations of ONLOOP and developing new projects. In addition, the successful candidate manages the personnel on the research team, including on-going training and supervision, conducting performance appraisals, as well as organizing communication strategies and team meetings.
Protocol Related Here's What You'll Get To Do:
- Collaborate with the Principal Investigators regarding grant applications, new research proposals, report preparation, presentations, manuscripts and development and review of study protocols.
- Prepare protocols for use.
- Develop case report forms and/or questionnaires.
- Organize science reviews and track deadlines.
- Keep abreast of regulations and policies governing clinical research and communicate to staff and research team members (e.g., Tri-council Policy Statement, ICH Guidelines, Good Clinical Practices). Develop policies and procedures related to the research program, ensuring external regulations and guidelines are followed.
- Develop informed consent documents based on regulations, REB consent templates and institutional requirements. Submit to REB; follow up on queries and changes. Prepare annual ethics renewals, make and submit changes based on protocol amendments as required.
- Develop study binders/file folders for study team use and ensure they are kept up to date.
- Participate in audits by SickKids and other regulatory bodies.
- Supervise literature reviews and keep current with study literature.
- Supervise database development and entry based on website database. Lock database once clean. Develop programming to produce regular database reports, with Principal Investigators and website vendor.
- Develop and monitor timelines for ONLOOP. Develop and maintain databases of other current studies, as applicable, and their status.
Research Participant Related
- Develop quality control guidelines for studies - eligibility confirmation, protocol compliance, scheduling of re-evaluations, etc.
- Monitor for and follow up on unanticipated events, including filing reports with internal and external regulatory bodies (REB), notification of collaborators, and/or participants.
- Oversee recruitment and respond to participant inquiries.
Human Resources / Financial
- Encourage and foster collaborative relationships with the study team at SickKids, Women's College Hospital, and healthcare teams at other centres that are involved. Engage and collaborate with health system partners.
- Recruit, train and supervise project staff, as needed
- Actively participate in team meetings or rounds to acquire and disseminate knowledge.
- Develop, manage and forecast study budgets.
- Monitor staff performance and assist PI with annual performance appraisals.
Here's What You'll Need
- A Master's degree in Epidemiology, Health Science or a related field with a minimum of 3 years experience in clinical research. Alternatively, you are a licensed healthcare professional with 5 to 7 years' related clinical research experience.
- A clinical professional degree would be preferred, as would certification as a clinical research associate (e.g., SOCRA accreditation).
- You have proven skills in grant writing, data and budget management, graphics. You are familiar with statistical software packages.
- Function independently yet collaboratively within a team.
- Effective communication, interpersonal, facilitation and project management skills.
- Strong leadership and mentoring skills.
- A commitment to understanding and aiding in the pursuit of equity, diversity and inclusion objectives.
Employment Type: Part-time temporary 19 month contract with modified benefits (i.e., health and dental insurance), 0.5 FTE
SickKids is committed to championing equity, diversity and inclusion in all that we do, fostering an intentionally inclusive and culturally safe environment that reflects the diversity of the patients, families and communities we serve. Learn more about workplace inclusion.
If you require accommodation during the application process, please reach out to our aSKHR team. SickKids can provide access and inclusion supports to eligible candidates to support their full engagement during the interview and selection process as well as to ensure candidates are able to perform their duties once successfully hired. If you are invited for an interview and require accommodation, please let us know at the time of your invitation to interview. Information received related to access, inclusion or accommodation will be addressed confidentially.
Technical difficulties? Email ask.hr@sickkids.ca with a short description of the issues you are experiencing. We will not accept resumes sent to this inbox but we are happy to respond to requests for technical assistance.
Tip: Combine your cover letter and resume into ONE document of 20 pages or less as you cannot upload multiple documents as part of your application.
About The Hospital for Sick Children
The Hospital for Sick Children (SickKids) is recognized as one of the world’s foremost paediatric health-care institutions and is Canada’s leading centre dedicated to advancing children’s health through the integration of patient care, research and education. Founded in 1875 and affiliated with the University of Toronto, SickKids is one of Canada’s most research-intensive hospitals and has generated discoveries that have helped children globally.
Its mission is to provide the best in complex and specialized family-centred care; pioneer scientific and clinical advancements; share expertise; foster an academic environment that nurtures health-care professionals; and champion an accessible, comprehensive and sustainable child health system.
SickKids is a founding member of Kids Health Alliance, a network of partners working to create a high quality, consistent and coordinated approach to paediatric health care that is centred around children, youth and their families.
SickKids is proud of its vision of Healthier Children. A Better World.™
Clinical Research Project Manager, ONLOOP
Top Benefits
About the role
Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) is one of the largest and most respected paediatric healthcare centres in the world. As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading-edge research and education. Our reputation would not have been built - nor could it be maintained - without the skills, knowledge and experience of the extraordinary people who come to work here every day. SickKids is committed to ongoing learning and development, and features a caring and supportive work environment that combines exceptionally high standards of practice.
When you join SickKids, you become part of our community. We share a commitment and determination to fulfill our vision of Healthier Children. A Better World .
Don't miss out on the opportunity to work alongside the world's best in paediatric healthcare.
Clinical Research Project Manager The Clinical Research Project Manager works closely with the Principal Investigators to plan and manage the overall research program and the research team. ONLOOP is a research program that helps adult survivors of childhood cancer in Ontario monitor for late effects from their cancer treatment. Responsibilities include long-term planning and day-to-day operations of ONLOOP and developing new projects. In addition, the successful candidate manages the personnel on the research team, including on-going training and supervision, conducting performance appraisals, as well as organizing communication strategies and team meetings.
Protocol Related Here's What You'll Get To Do:
- Collaborate with the Principal Investigators regarding grant applications, new research proposals, report preparation, presentations, manuscripts and development and review of study protocols.
- Prepare protocols for use.
- Develop case report forms and/or questionnaires.
- Organize science reviews and track deadlines.
- Keep abreast of regulations and policies governing clinical research and communicate to staff and research team members (e.g., Tri-council Policy Statement, ICH Guidelines, Good Clinical Practices). Develop policies and procedures related to the research program, ensuring external regulations and guidelines are followed.
- Develop informed consent documents based on regulations, REB consent templates and institutional requirements. Submit to REB; follow up on queries and changes. Prepare annual ethics renewals, make and submit changes based on protocol amendments as required.
- Develop study binders/file folders for study team use and ensure they are kept up to date.
- Participate in audits by SickKids and other regulatory bodies.
- Supervise literature reviews and keep current with study literature.
- Supervise database development and entry based on website database. Lock database once clean. Develop programming to produce regular database reports, with Principal Investigators and website vendor.
- Develop and monitor timelines for ONLOOP. Develop and maintain databases of other current studies, as applicable, and their status.
Research Participant Related
- Develop quality control guidelines for studies - eligibility confirmation, protocol compliance, scheduling of re-evaluations, etc.
- Monitor for and follow up on unanticipated events, including filing reports with internal and external regulatory bodies (REB), notification of collaborators, and/or participants.
- Oversee recruitment and respond to participant inquiries.
Human Resources / Financial
- Encourage and foster collaborative relationships with the study team at SickKids, Women's College Hospital, and healthcare teams at other centres that are involved. Engage and collaborate with health system partners.
- Recruit, train and supervise project staff, as needed
- Actively participate in team meetings or rounds to acquire and disseminate knowledge.
- Develop, manage and forecast study budgets.
- Monitor staff performance and assist PI with annual performance appraisals.
Here's What You'll Need
- A Master's degree in Epidemiology, Health Science or a related field with a minimum of 3 years experience in clinical research. Alternatively, you are a licensed healthcare professional with 5 to 7 years' related clinical research experience.
- A clinical professional degree would be preferred, as would certification as a clinical research associate (e.g., SOCRA accreditation).
- You have proven skills in grant writing, data and budget management, graphics. You are familiar with statistical software packages.
- Function independently yet collaboratively within a team.
- Effective communication, interpersonal, facilitation and project management skills.
- Strong leadership and mentoring skills.
- A commitment to understanding and aiding in the pursuit of equity, diversity and inclusion objectives.
Employment Type: Part-time temporary 19 month contract with modified benefits (i.e., health and dental insurance), 0.5 FTE
SickKids is committed to championing equity, diversity and inclusion in all that we do, fostering an intentionally inclusive and culturally safe environment that reflects the diversity of the patients, families and communities we serve. Learn more about workplace inclusion.
If you require accommodation during the application process, please reach out to our aSKHR team. SickKids can provide access and inclusion supports to eligible candidates to support their full engagement during the interview and selection process as well as to ensure candidates are able to perform their duties once successfully hired. If you are invited for an interview and require accommodation, please let us know at the time of your invitation to interview. Information received related to access, inclusion or accommodation will be addressed confidentially.
Technical difficulties? Email ask.hr@sickkids.ca with a short description of the issues you are experiencing. We will not accept resumes sent to this inbox but we are happy to respond to requests for technical assistance.
Tip: Combine your cover letter and resume into ONE document of 20 pages or less as you cannot upload multiple documents as part of your application.
About The Hospital for Sick Children
The Hospital for Sick Children (SickKids) is recognized as one of the world’s foremost paediatric health-care institutions and is Canada’s leading centre dedicated to advancing children’s health through the integration of patient care, research and education. Founded in 1875 and affiliated with the University of Toronto, SickKids is one of Canada’s most research-intensive hospitals and has generated discoveries that have helped children globally.
Its mission is to provide the best in complex and specialized family-centred care; pioneer scientific and clinical advancements; share expertise; foster an academic environment that nurtures health-care professionals; and champion an accessible, comprehensive and sustainable child health system.
SickKids is a founding member of Kids Health Alliance, a network of partners working to create a high quality, consistent and coordinated approach to paediatric health care that is centred around children, youth and their families.
SickKids is proud of its vision of Healthier Children. A Better World.™