Working Here at St. Michael's Hospital

You are viewing a vacancy at St. Michael’s Hospital, now a member of a new health network along with Providence Healthcare and St. Joseph’s Health Centre. Together, we are committed to a shared purpose of advancing the health of our patients and our urban communities.

Research Compliance & Education Specialist AHRC

Competition #:834168

Job Title:Research Compliance & Education Specialist AHRC

Job Category:Research

New Work Type:Full-Time Permanent

Positions Available:1

Union Affiliation:NU

Posted Date:26/11/18

Closing date:16/12/18

Salary Range:$34.87 - $45.18 per hour

FTE Assignment (Cas=0.000001):1.0

Focusing on excellence in clinical research methodology and operations, the AHRC houses leading research methodologists and statisticians with distinct expertise in both randomized and non-randomized clinical research designs, and qualitative research methodologists for mixed methodologies.

 A one-stop-shop for clinical research, the AHRC’s services include:

  • Study design, methodology, epidemiology, registry science, and qualitative research
  • Biostatistics consulting
  • Protocol and case report form development
  • Project, site, data, and safety management
  • Qualitative data collection, coding, and analysis
  • Quantitative data analysis and medical writing
  • Multi-centre clinical research coordination
  • IT support for clinical research
  • Contracts and financial management
  • Quality assurance and Monitoring

Since launching in May 2009, the AHRC has been engaged in more than 150 projects in a variety of therapeutic areas such as neurology, infectious diseases, nephrology, critical care medicine, emergency medicine, and cardiovascular medicine. Our projects range from single centre projects to large, international, multicentre projects with thousands of patients.

The Research Compliance & Education Specialist is a member of the AHRC Research Quality & Privacy team whose primary accountabilities are the:

  • To plan, develop materials, and implement new services for academic researchers and institutions across Canada, focused on delivering clinical research training services
  • To plan and conduct both on-site and remote clinical research monitoring/auditing activities. On-site visits to research study sites will require at least 50% travel both nationally and internationally. This position operates with limited supervision, with guidance from the Clinical Research Specialist and Manager, Research Quality and Process.

DUTIES & RESPONSIBILITIES:

Quality Planning, Control and Improvement:

  • Track and manage AHRC training files and processes
  • Develops SOPs, tools and templates for research teams and institutions to facilitate efficient conduct of research
  • Identify and disseminate best practices and facilitate quality improvement initiatives within research teams and institutions
  • Support research teams and institutions in preparing for external audits
  • Conduct quality audits both internal and external to the AHRC

Knowledge Building and Fostering Collaborative Partnerships:

  • Initiate and maintain collaborative relationships with key individuals and departments to ensure a research team / institution wide approach to research quality
  • Plan, implement and deliver education sessions related to research conduct and quality management
  • Act as a resource in interpreting regulatory, privacy and research guidance documents
  • Identifies and promotes internal and external sources of research expertise and education

Monitoring

  • Plans and conducts both on-site and remote monitoring activities as defined in the protocol, GCP, SOPs and Sponsor requirements
  • Evaluates appropriateness of research sites to conduct the study, reviews and verifies site documents as required by protocol and GCP
  • Conducts source data verification (SDV) and other activities related to ensuring quality of trial data, adherence with applicable regulations and ensuring the rights and well-being of human subjects are protected
  • Reviews accuracy, completeness and timeliness of completed study records, case report forms (CRFs), and other documents
  • Documents monitoring activities in writing, using appropriate report formats, and promptly communicates deficiencies to appropriate stakeholders and takes necessary actions
  • Identifies investigator misconduct and/or fraud. Presents findings to stakeholders
  • Works cooperatively with clinical research staff and investigators to address their concerns and to communicate findings that can lead to improved clinical research study performance and/or compliance.
  • Participates in meetings and training activities.
  • Conducts assessments of potential Serious Adverse Events
  • Reports Serious Adverse Events to regulatory agencies
  • Works with sites to review barriers to recruitment, local site matters, and other related tasks
  • Prepares study monitoring plans, monitoring reports and related documents.
  • Communicates with sites, internal study team and study sponsor
  • Other related research quality assurance duties as necessary

QUALIFICATIONS:

  • Minimum educational requirement of a bachelor’s degree
  • Must have 5+ years of clinical research experience (including monitoring and quality processes) and adult education development experience
  • Recognized certifications (e.g. CCRP) are an asset
  • Requires ability to travel nationally, to the USA and to international destinations
  • Strong understanding of ICH/GCP guidelines, and the Canadian and US regulatory environments
  • Knowledge of privacy legislation (such as PIPEDA, PHIPA, US HIPAA) as it relates to the conduct of clinical research
  • Ability to understand and interpret complex clinical study protocols
  • Experience using electronic data capture; familiarity with REDCap and RAVE database software is an asset
  • Demonstrated initiative, willingness to learn
  • Excellent interpersonal and written and verbal communication skills
  • Ability to work independently and in a team environment and under pressure with tight deadlines
  • Bilingualism (French) an asset

#LI-MR1