University of Waterloo

Returning Candidate?

Research Ethics Advisor

Research Ethics Advisor

Requisition ID 
2018-2664
Job Category  
Research
Department 
5470 - Office of Research
Job Status 
Temporary Appointment (Contract)
Hiring Range 
$57,834 - $72,293

More information about this job

Overview

Term: 1 Year

 

The role of REA is integral to the management and operation of the ORE. The REA serves as the primary liaison between the ORE and the researcher and his/her research team. The REA is responsible for facilitating the research ethics submission and review process and overseeing the effectiveness and efficiency of the online ethics review system. The REA ensures that the daily operations comply with internal and external requirements. The REA roles support the four research ethics review committees and two advisory committees along with internal and external stakeholders (e.g., researchers, government agencies, accreditation committees/auditors, faculty/department and other administrative staff) regarding the requirements for and outcomes of the ethics review of proposed research. The REA is the key person in the ORE responsible for developing reports and tracking required information to establish performance metrics for the ORE.

 

The REA ensures that all relevant resources for researchers are kept current. There are multiple REA positions within the ORE. Some REAs will focus primarily on facilitating ethical human research where others will focus on facilitating ethical animal research. This job description outlines the accountabilities which are common to all REAs and also identifies unique accountabilities. The REAs are required to provide back-up and support for each other on an “as needed” basis. These areas in which back up is required include: receipt and triage of new events/applications, providing secretariat support at committee meetings, ensuring information entered in the administrative system is accurate or correcting information if required, and handling routine queries regarding compliance obligations.

 

This role is contingent on funding.

Responsibilities

Facilitate and conduct ethical analysis of research

  • Point person for all inquiries and questions regarding research compliance obligations including the requirements and processes involved with obtaining and maintaining ethics clearance
  • Provide consultation to faculty, student and staff researchers regarding the ethics review process and the required ethical obligations according to institutional, national and provincial requirements and guidelines
  • Conduct delegated review of specified minimal risk ethics applications
  • Review revisions of designated research ethics applications to ensure the reviewers’ comments have been addressed, meet the required ethical requirements and guidelines, and recommend approval for the research to proceed
  • Review amendments/modifications of protocols/ethics applications to assess risk level and recommend approval for the change to be made to the research
  • Promptly and effectively respond to all telephone, mail, and email/web inquiries and questions from faculty, staff, students from any of the six faculties, affiliated Colleges or research institutes, including non-Waterloo researchers or partners regarding research compliance including the ethics review process and administrative requirements
  • Provide advice and assistance about Waterloo’s research ethics process, guidelines, policies and other information as needed by relaying it clearly and accurately
  • Interpret international, federal, provincial, and institutional policies and procedures as it related to Waterloo’s ethics review process and communicate these policies and procedures to researchers, staff, and students
  • Maintain professionalism at all times in conflict situations; use interpersonal skills to handle sensitive and delicate situations and cases (e.g., where research grant support is conditional upon ethics clearance or when an application is time-sensitive or in need of review by multiple offices/levels (e.g., Safety Office) 
  • evelop and maintain positive working relationships directly with researchers and ethics committee and advisory committee members to build credibility and encourage proactive discussions and anticipatory analysis of ethical issues in the application undergoing review
  • Make recommendations to supervisor on ways to clarify ethical research compliance requirements then draft new guidelines or standard operating procedures that interpret these compliance requirements for Waterloo researchers for review by managers
  • Unique to the REA for human research:
  • establish, recruit, train, and monitor the quality, and day to day operations and ethical reviews of the course-based research Delegated Ethics Review Committee according to the terms of reference
  • Unique to the REA for animal research:
  • oversee the coordination of the post-approval monitoring program in collaboration with the Senior Animal Health Technician – PAM
  • Coordinates Animal Care Committee (ACC) tours and inspections by Consulting Veterinarian, Ontario Ministry of Agriculture and Rural Affairs (OMAFRA) and Canadian Council on Animal Care (CCAC) including the maintenance of records, distribution of reports associated with tours and inspection, and monitors responses and follows through on any required actions
  • Applies procedures for effective monitoring of animal purchases with UWaterloo Purchasing office

 

Utilize Business Tools, Resources and Processes - Triage all incoming events including new applications, annual continuing review, adverse events/incidents, modifications, post approval monitoring, protocol deviations, incidental findings, and decide on the appropriate review route.

  • Triage applications to appropriate review route (i.e., either single person delegated, committee delegated or full committee as appropriate)
  • Develop standard operating procedures for back office operations including the Central Animal Facility and other satellite facilities
  • Review applications for completeness and compliance with submission requirements
  • Coordinate the timely review of all research ethics applications through all stages of the ethics clearance process by: a) receiving and screening submissions; b) assessing the need for additional/missing information; c) preparing application files for delegated review or full committee review;  d) preparing ethics committee agenda, e) taking minutes of ethics committee and sub-committee meetings; f) monitor the status of applications that are pending including ensuring timely submission and response to committee comments; g) coordinate the approval process of study modifications, protocol deviations, incidental findings, and adverse events, and h) ensure reviews of continuing review reports/post-approval monitoring is accomplished and identify issues for follow-up where appropriate based on the ORE standard operating procedures.
  • Verify that the required ethics training has been completed by Waterloo researchers named on applications and communicate to researchers if this training has not been completed
  • Independently apply standard operating procedures and guidelines to decide on the ethics review route based on several factors and criteria (e.g., nature of event, level of risk, departmental affiliation, and vulnerability)
  • Maintain the integrity of all electronic and paper files and documents including the input of information into ethics system, auditing of records and files, following up with researchers for outstanding or missing information/documents, unapproved submission, and annual progress reports or suspended/lapsed approvals
  • Coordinate the ordering and renewal of key journal subscriptions accreditation/memberships for ORE staff, and maintenance of a library
  • Produce a pre-determined list of ongoing descriptive statistical reports concerning key operational benchmarks

 

Provide Stakeholder Support and Influence - Secretariat for Waterloo’s Ethics Review and Advisory Committees or the Animal Care Committee; develop effective working relationships with external and internal stakeholders

  • Provide day-to-day operational and secretariat support to the research ethics and advisory committees by preparing the agenda and minutes, ordering meals, taking care of room bookings and equipment or IT requests
  • Maintain up to date committee files such as membership lists, reports, terms of reference, minutes, and orientation materials
  • Coordinate and prepare ethics staff and committee members for site visits from external provincial or federal audit/compliance teams. This includes the advance preparation of audit reports and other supporting documentation, anticipating questions/issues, explaining specific ethics processes, forms, and templates, and following-up with requests from auditors for additional information or reports
  • Communicate and troubleshoot with researchers regarding non-compliant or incomplete paperwork
  • Synthesize required external reports involving external agencies’ operational audits (e.g., Tri-agencies, Health Canada, NIH, Clinical Trials Ontario, Canadian Council on Animal Care, OMAFRA).
  • Manage internal and external inspections and national or provincial audit or site-visits
  • Clearly communicate and explain compliance requirements for common international, federal, and provincial regulations and relevant University of Waterloo policies and procedures arising from stakeholders (e.g., Tri-agencies, Health Canada, DHHS, Safety Office, Office of Research, IST, uWaterloo Secretariat)
  • Participate in developing content for ongoing communication initiatives (e.g., listserv, annual report, website)

 

Demonstrate business knowledge 

  • Identify sources from which to obtain required information concerning grants, financial obligations, institutional policies
  • Manage special events such as annual meetings

 

Support Ethics Administration System - Administrator (i.e., super user) for Waterloo’s Research Ethics researcher portal and web/online ethics application and review system.

  • Oversee the maintenance and monitor the functioning of the ethics review system and be the point person with the Office of Research Information Systems Specialist and Computer Systems Specialist by advising on: a) human and animal ethics review processes, b) identify process efficiency improvement opportunities, c) implement smart form and other system features, d) researcher notifications, update screens, develop templates and reports
  • Ensure system workflow reflects Standard Operating Procedures (SOPs) for back office and Committee operations and required use of system/database for users and administrators; notify Senior Manager if gaps identified
  • Establish, monitor, and update the Sharepoint site for all Committees
  • Train Committee members to use the Sharepoint site, troubleshoot problems, and prepare instructional materials as needed
  • Maintain the Sharepoint library to ensure a current and complete list of relevant SOPs, policies, and professional development materials are available and accessible for Committee members
  • Monitor and maintain the internal drive for file sharing (R drive) to ensure the structure is efficient and appropriate to meet the needs of the ethics office staff
  • Liaise with Office of Research Operations and Communications staff to identify changes which need to be made on the human and animal websites with respect to development, maintenance, and upgrades
  • Decide on record retention and destruction according to uWaterloo and ORE guidelines
  • Unique to the REA for animal research:
    • ensure animal purchases do not exceed approved limits

 

Deliver Training and Development: Assist with development and delivery of research compliance training whether one on one (e.g., new members of committees, or for small to medium sized audiences)

  • Conduct orientation for new committee members
  • Develop materials for workshops or training sessions
  • Lead ethics and integrity compliance training sessions for small to medium sized audiences
  • Assist in the design and development of training content where relevant (e.g., completing an application)
  • Identify areas where training is needed and proposes ideas to ORE team  concerning new training initiatives or needs
  • Assist in analyzing feedback received from training sessions for the purposes of improving future training sessions
  • Unique to the REA for animal research:
    • Develop schedules for training sessions ensuring trainers have been secured for each session in a timely fashion
    • Manage the Desire 2 Learn and MyHRInfo registrations and course content for all animal training.

 

Qualifications

  • A university degree in a research related field (health sciences or social sciences is preferred) or advanced diploma which involved a research course or project involving human participants or animals OR Equivalent extensive ethics administration or research administration and experience at the coordinator level, (5-7 years) OR Completion of relevant professional designation in ethics or research administration plus 3-5 years of experience in ethics administration
  • 3 to 7 years of experience in ethics administration or research administration
  • Technical: Human Research: TCPS2 CORE tutorial CITI Canada – Good Clinical Practice CITI Canada – Social Sciences and Humanities Module Animal Research: AR0001 – Basic Animal Research Theory AR0004, AR0010 CAF Orientation Theory and Tour AR0014 – Advanced Animal Research – Theory; uWaterloo Mandatory Courses: SO1001 – Safety Office Orientation SO1081 – Safety Office Workplace Violence Integrity matters (OHD 120) 
  • MS Word, Excel and Powerpoint (Basic Level)
  • Excellent written and verbal communication skills
  • Experience in a customer service role
  • Demonstrated ability to plan, prioritize, and manage multiple demands and high volume
  • Ability and flexibility to apply established procedures to individual situations
  • Proven ability to deal with confidential materials and information
  • Ability to respond with diplomacy and tact, to individuals who have a broad range of knowledge and experience with the research ethics process
  • Advice and decisions provided to Waterloo researchers often requires a delicate balance of professionalism, client service support, and teaching and instruction