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Research Compliance, Risk and Education Manager

3 months ago

Canada, CA Lunenfeld-Tanenbaum Research Institute of Mount Sinai Hospital Full time

Department: Lunenfeld Tanenbaum Research Institute
Position: Research Compliance, Risk and Education Manager

Position Description

About Us: The Lunenfeld-Tanenbaum Research Institute at Sinai Health, a University of Toronto affiliated research centre, is one of the world's leading centres in biomedical research. With ground-breaking discoveries in research areas such as diabetes, genetic disorders, cancer and women’s and infants’ health, the Institute is committed to excellence in health research and the training of young investigators. Strong partnerships with the clinical programs of Mount Sinai Hospital and Hennick Bridgepoint Hospital ensure that scientific knowledge is used to promote human health. Your significant contributions will assist in improving our clinical research.

Position Overview: We are seeking an experienced and strategic-minded individual to join our team as a Research Compliance, Risk and Education Manager. In this pivotal role, you will manage all aspects of clinical research compliance and educational initiatives within our institution. Reporting to the Deputy Director of Clinical Research, Sinai Health, you will play a key role in ensuring adherence to regulations, policies, and ethical standards, while also promoting awareness and understanding among our staff and collaborators.

Key Responsibilities:

  1. Quality Assurance and Compliance:
    • Lead efforts to monitor and enforce compliance with applicable regulations, guidelines, and institutional policies governing research activities.
    • Maintain up-to-date knowledge of relevant Health Canada regulations, guidelines and industry standards.
  2. Policy Development:
    • Drive the development and revision of institutional policies related to research integrity, compliance, and data management, staying abreast of regulatory changes and best practices.
  3. Training and Education:
    • Develop and implement training programs and materials on research compliance topics for researchers, staff, and stakeholders.
    • Provide ongoing education and updates regarding changes in regulations and best practices.
    • Assist in the development and review of research protocols, informed consent forms, and other regulatory documents.
  4. Audit and Monitoring:
    • Conduct regular audits and assessments to evaluate compliance with research protocols and Health Canada regulations, identify areas for improvement, and monitor implementation of corrective actions to ensure timely resolution of compliance issues as needed.
    • Maintain detailed records of compliance activities, including audits, inspections and training sessions.
    • Ensure that all research documentation is accurate, complete and accessible for regulatory review as required.
  5. Investigations and Reporting:
    • Follow institutional policies to manage investigations of alleged research misconduct or non-compliance, ensuring thorough documentation and reporting to internal and external stakeholders.
    • Foster collaboration with other departments, including Research Administration, Research Ethics and Risk Management, regulatory agencies, and external partners to promote a culture of research integrity and compliance throughout the institution.
    • Identify potential risks to research quality and compliance, maintain a clinical research risk registry and develop mitigation strategies to ensure the organization’s compliance with regulatory requirements.
  6. Reporting:
    • Submit annual scorecard and progress reports to the VP Research, Enterprise Risk Management, MAC, and other committees as requested.

Qualifications

  • Advanced degree (Master’s or higher) in a relevant field (e.g., life sciences, health sciences, nursing, law, ethics).
  • 5 years of progressive experience in research integrity, compliance, regulatory affairs, project management or related fields, with demonstrated leadership and managerial capabilities.
  • In-depth knowledge of relevant regulations and guidelines, including but not limited to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), the Food and Drugs Act (Canada) and related regulations, the ICH Harmonised Tripartite Good Clinical Practice Consolidated Guideline (ICH-GCP), the Declaration of Helsinki and applicable privacy and data protection laws.
  • Expertise in research data management, from technical and/or legal perspectives, preferred.
  • Strong communication and interpersonal skills, with the ability to engage and educate diverse stakeholders effectively.
  • Ability to work cooperatively in a team-oriented environment.
  • Exceptional attention to detail, analytical skills, and problem-solving abilities.
  • Proven ability to thrive in a fast-paced environment and effectively manage multiple priorities.

Application Instructions

Please submit:

  1. Cover letter (including contact information for three references)
  2. CV

Applications are accepted until Sunday August 11th, 2024 or until a suitable candidate is identified. Applications will only be accepted through Interfolio.

The Lunenfeld-Tanenbaum Research Institute is committed to equity, diversity, and inclusion, and welcomes applications from all qualified individuals, including those from underrepresented communities. We offer a competitive salary and benefits package, as well as opportunities for professional development and growth. If you are passionate about clinical or discovery research and infectious disease and are looking for a challenging and rewarding opportunity, please apply today.

Sinai Health System recognizes that scholars have varying career paths and that career interruptions due to personal circumstances can be part of an excellent academic record. Candidates are encouraged to explain any personal circumstances in order to allow for a fair assessment of their application. Search committee members have been instructed to give careful consideration to, and be sensitive to the impact of, career interruptions in their assessments.

Sinai Health System is strongly committed to diversity within its community and especially welcomes applications from racialized persons / persons of colour, women, Indigenous / Aboriginal People of North America, persons with disabilities, and members of sexual minority groups, and others who may contribute to the further diversification of ideas.

OTHER INFORMATION RELEVANT TO THE POSITION

In accordance with Institute’s policy and legislated health and safety requirements, employment is conditional upon the verification of credentials, completion of a health review, and demonstrating proof of immunity and vaccination status of vaccine-preventable diseases.

Sinai Health System is a scent-sensitive environment, and all members of the community are expected to refrain from wearing or using scented products while visiting or working at the Institute. We also support a barrier-free workplace supported by the Institute’s accessibility plan, accommodation and disability management policies and procedures. Should you require accommodation at any point during the recruitment process, including accessible job postings, please contact the Lunenfeld-Tanenbaum Human Resources Department.

Posting open until August 11, 2024. We thank all candidates for applying. Only those selected for an interview will be contacted.

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