Clinical Research Project Manager-RI

SickKids; Toronto; On-site; CAD 80,000 - 110,000; Full time

Job summary

SickKids is seeking a Clinical Research Project Manager to oversee and manage various clinical studies within the Labatt Family Heart Centre. The successful candidate will engage with Principal Investigators and healthcare teams, ensuring compliance with regulations and ensuring project success through effective management. This role contributes significantly to the research landscape aimed at improving child health, with opportunities for professional development and impact.

Benefits

Eligible for employee benefits including health, dental, and life insurance

Opportunity to make a significant impact in child health

Qualifications

• Minimum of three years' experience working as a Clinical Research Project Coordinator.
• Certification as a clinical research professional (e.g., SOCRA) preferred.
• Experience with Health Canada Regulated trials and REB applications required.

Responsibilities

• Plan and manage clinical research studies, including day-to-day operations.
• Collaborate with PIs on regulatory submissions and study protocols.
• Monitor timelines for studies and manage multiple projects efficiently.

Skills

Effective communication

Interpersonal skills

Project management skills

Leadership qualities

Education

Bachelor's degree in Science or Health Sciences

Master's degree in relevant research field

Job description

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*Compensation commensurate with experience

Position Description

Reporting to the Labatt Family Heart Centre Clinical Research Manager, the Clinical Research Project Manager works closely with the Heart Centre Principal Investigators (PI) to plan and project manage new and ongoing clinical research studies. This includes the long-term planning of on-going projects, day-to-day operations of on-going projects (REB/Health Canada Applications, study start up, recruitment, closeout, protocol development, study budgets, monitoring and tracking study compliance/timelines/milestones). The successful candidate will develop close working relationships with the medical and health care professional staff that provide clinical care to the study patients, both at the SickKids and other institutions.

Here's what you'll get to do

• Collaborate with PIs in the development and review of study protocols, regulatory submissions, research agreements, report preparation, presentations, and grant applications as needed
• Keep abreast of regulations and policies governing clinical research and communicate these policies to research team members
• Develop informed consent documents based on regulations, REB consent templates and institutional requirements.
• Prepare REB applications including new applications, amendments, SAE reporting and renewals/closures. Submit documents to REB; following- up on queries and required application changes.
• Develop study binders and Trial Master Files for study team use and ensure they are kept up to date
• Participate in audits, site visits and monitoring by SickKids and other regulatory bodies
• Keep current with study literature
• Complete data entry as required
• Develop and monitor timelines for existing studies and balance the demands of multiple projects
• Develop quality control guidelines for studies ' e.g. eligibility confirmation, protocol compliance, scheduling of re-evaluations
• Monitor serious adverse events or drug reactions and reporting to PI. Follow-up on adverse events including filing reports with internal and external regulatory bodies (REB), notification of collaborators, and/or patients
• Design/develop promotional strategies, including newsletters and letters to parents
• Carry out patient recruitment
• Encourage and foster collaborative relationships with the healthcare team at SickKids, other participating centres and other project stakeholders
• Develop, manage and forecast study budgets for industry sponsored and investigator initiated regulated and non-regulated trials
• Develop training sessions on study requirements
• May be required to provide oversite and training of volunteers and trainees

Here's what you'll need

• Bachelor's degree in Science, Health Sciences or related field
• Master's degree in relevant research field considered an asset
• Minimum of three years' experience working as a Clinical Research Project Coordinator or equivalent
• Previous experiences carrying out Health Canada Regulated drug and/or device trials
• Certification as a clinical research professional (e.g., SOCRA certificate) preferred
• Previous experience with protocol development, consent form development and previous experience developing and submitting REB application required
• Previous experience in the development of REDCap surveys/questionnaires, databases, etc considered an asset
• Familiarity with finance management and industry sponsored budget development/negotiation an asset
• Ability to function both independently and collaboratively within a team
• Effective communication, interpersonal, facilitation and project management skills
• Strong leadership qualities
• A commitment to understanding and aiding in the pursuit of equity, diversity & inclusion

Here's what you'll love

• This position is eligible for employee benefits coverage including but not limited to; health, dental and life insurance. The full benefits package will be discussed at the time of offer.
• The opportunity to make an impact. Regardless of your role or professional interest, you will be making a difference at SickKids and contributing to our vision of Healthier Children. A Better World .

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.

Accessibility & Accommodation

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.

How To Apply

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