Research Quality, Education - Toronto, Canada - Holland Bloorview Kids Rehabilitation Hospital

Holland Bloorview Kids Rehabilitation Hospital

Verified Company

Toronto, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Position Title:
Research Quality, Education & Compliance Specialist

Status:
Temporary, Full-time (1-year contract)

Start date:
June 5, 2023

End date:
June 28, 2024

Program:
Bloorview Research Institute

The Research Quality, Education & Compliance Specialist is an integral team member supporting research quality and excellence.

Specifically, the Specialist is responsible for the coordination of implementing institutional standards for research studies, and facilitation of activities aimed at enhancing and maintaining quality assurance and regulatory compliance.

The Specialist serves as a resource and support for clinical research teams.

The incumbent must be willing to work collaboratively and cooperatively in a challenging and dynamic environment and will be responsible for the activities outlined below.

Key Responsibilities

Support Research Operations within the Quality and Regulatory Compliance Program
Develop SOPs and standard templates in collaboration with Bloorview Research Institute leadership and the Research Ethics Office to ensure efficient and compliant quality function
Liaise with investigators and research teams to ensure that studies are conducted in compliance with Good Clinical Practice (GCP) and applicable regulatory requirements
Support the regulated clinical trials teams in ensuring all trial processes are in accordance with guidelines as set forth by Health Canada, ICH-GCP, and applicable international regulatory authorities
Develop and/or participate in the development and delivery of research personnel training and educational curriculum
Provide resources to other clinical research staff by identifying internal and external educational opportunities, organizing community of practice meetings and delivering educational offerings driven by quality audit findings (e.g. forms and checklists, educational training, regulatory advice/consultation, etc.) for investigators and research staff
Identify needs and deliver ongoing orientation, education and training to scientists, researchers and staff involved in research
Collaborate and communicate with other N2 and TAHSN quality assurance offices to share best practices and opportunities
Support quality assurance for all research projects at Bloorview Research Institute
Provide coordination/support for compliance and/or regulatory audits and inspections
Monitor quality assurance of research projects at HB according to established framework
Investigate identified quality issues brought forward by stakeholders on an adhoc basis
Lead the resolution of quality issues through stakeholder engagement, recommendations and support to the research teams involved, and the environmental and regulatory scans to determine best practice

As a role model and champion you will work to identify and integrate safe, best practices into daily activities to foster the delivery of safe and exemplary care.

The responsibilities described above are representative and are not to be construed as all-inclusive.

Qualifications/Skills:

25 years recent related clinical research coordination/ethics and regulatory experience
University degree in Health Sciences required
Must have demonstrated experience with regulated clinical trials
Advanced knowledge of the clinical research process, research ethics, and all associated regulations and guidelines
Strong interpersonal skills
Strong oral and written communication skills
Must have excellent customer service work ethic and be a team player
Superior time management, organizational skills, accuracy and attention to detail
Ability to multitask, prioritize work effectively and meet multiple deadlines
Demonstrated proficient computer skills with strong skills in Excel Spreadsheet development and use (MS Excel, Word, Power Point, Outlook, Access, webbased databases, internet) required
Experience using webbased programs a definite asset