The Rick Hansen Institute is a Canadian-based not-for-profit organization committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries (SCI).
We are looking for a Compliance Coordinator who will ensure that RHI’s business practices related to privacy and security, clinical trials, and general organizational compliance and quality meet legislative, regulatory and contractual requirements, international standards and best practices.
This position will foster a culture of compliance and quality with the support of management and all employees to ensure overall compliance and quality. The Compliance Coordinator will follow up on all findings and corrective and preventative action items as required, and work with external parties in any compliance reviews or investigations, as necessary.
The Compliance Coordinator will stay up-to-date with both internal and external changes in business activities, technology, legislative, regulatory and contractual requirements, and best practices to ensure organizational adaptation and compliance, and to provide updates and escalate critical issues/concerns, as required.
If you have a background in compliance and are self motivated, we encourage you to apply for this position.
Develops, maintains, and monitors a quality program to improve general organizational compliance and quality.
Developing, implementing, monitoring, and improving the general quality program as necessary, including:
- Developing and updating general organizational policies and procedures [e.g., processes regarding the management of policies, SOPs and forms, documentation of training, information security (non-technical), conflicts of interest, whistleblowing, Canadian Anti-Spam Legislation (CASL), policy and procedure deviations, and complaints]; and
- Providing training and reminders to all employees and applicable third parties.
Providing support to improve the compliance and quality of process owners’ specific and critical activities, as required. This includes but is not limited to:
- Coordinating and documenting information security incidents; and
- Reviewing and revising board and departmental policies and SOPs.
Reviewing contracts and providing advice and oversight on any modifications or amendments and ensuring contracts are executed according to policies and SOPs;
Monitoring compliance with Imagine Canada’s Standards Program, and writing and submitting reports annually in order to maintain accreditation.
Performing internal reviews of RHI critical activities upon request of senior management.
Other work-related duties as required and assigned.
Clinical Study Quality Assurance (QA):
Ensures applicable national and international regulatory requirements and standards are met.
Primary responsibilities include:
- Reviewing and approving GCP and GMP processes and related documentation (e.g., SOPs, work instructions, tools, protocols, and reports), including vendor qualification.
- Support the preparation of sites for regulatory inspections.
- Providing guidance on issues as required.
Maintains a privacy management program that is accountable and abides by Canadian federal, provincial and territorial legislation and regulations, international standards and best practices to ensure compliance with:
- Privacy legislation for all jurisdictions within which RHI currently operates and could possibly operate in the future;
- RHI’s contractual requirements.
Primary responsibilities include:
Monitoring privacy compliance, assessing effectiveness and revising program controls as necessary, including but not limited to:
- Developing and providing orientation and refresher privacy training and awareness to all employees and applicable third parties or providing them with alternative training;
- Developing, updating and reviewing Data Sharing Agreement (or similar);
- Performing internal privacy reviews/audits; and
- Ensuring risk assessments are performed where necessary, i.e. third party vetting, privacy impact assessments (PIAs).
Coordinating and following up on external PIAs, audits and inspections.
Managing privacy breaches, inquiries, and complaints.
The ideal candidate will have:
- Bachelor’s Degree in relevant are of study.
- Formal training in compliance and/or certification in privacy is desirable. Also formal training and/or certification in contract law, quality assurance and/or clinical research would be an asset.
- At least 3 years of compliance and/or quality assurance experience in a complex environment.
- Experience with privacy issues related to managing research data, data de-identification, data access requests.
- Experience with contracts management and contract law would be an asset.
- Experience with records management, technical writing, CASL, information security, presentations, auditing, and clinical research would be an asset.
- Strong organizational and adaptability skills to manage a diverse workload and multiple projects at the same time and keep track of multiple and varying regulatory and contractual obligations, with minimum supervision.
- Excellent interpersonal skills and demonstrated experience working in a team setting.
- Critical thinking skills.
- Superior technical writing skills and proficiency with MS Word, Excel, and Powerpoint.
- Attention to detail.
- Training and presentation skills would be an asset.