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Research Ethics Advisor

Date: April, 2016
Reports to (Job Title): Senior Manager, Research Ethics
Jobs Reporting (Job Titles): Co-op Student(s)
Department: Office of Research

Location:

Main Campus, Needles Hall

Grade:

USG 9
35 hr/wk


Primary Purpose

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

CONTEXT:
Research ethics roles are unique from any other position in the Office of Research and many other administrative roles in areas such as accounting or human resources. This job, unlike other disciplines which are heavily regulated and benefit from clear standards, professional association-driven performance requirements, and detailed regulations, has no central accreditation or other compliance-oriented body the incumbent can turn to inform their decision-making.   As a result, this is a role that requires astuteness and situational problem-solving ability. The incumbent must be able to manage ambiguity and uncertainty including troubleshooting problems. Confidentiality and discretion are key elements of this job. This job also requires an ability to think critically and analytically. The job requires strong skills in decision-making, organization, and time management. An inability to manage these elements will result in reputational damage to uWaterloo researchers (e.g., faculty/staff/students), the broader Office of Research, and the University of Waterloo. Poor performance will also directly affect a Waterloo researcher’s ability to receive ongoing research funding from one or more of the federal Tri-agencies, US or international sponsors and prevent critical research from occurring at Waterloo in a timely fashion to meet uWaterloo’s strategic objectives.  The Ethics office reviewed nearly 3,174 research event files in 2014 which is a 48% increase from 2006. In 2014, the ORE managed approximately 2,270 active protocols at any one time. These numbers continue to increase exponentially each year for both human and animal research. In 2014, 86% of Waterloo faculty were involved with human participant research compared to 57% two years ago. New human research applications reviewed in 2013-2014 represented $19.3 million in Waterloo’s research funding. Unlike other Canadian universities, delegated review occurs within the ORE and is conducted by the REAs and Managers. 97% of new applications are reviewed in a delegated fashion as compared to a mere 3% of applications which are reviewed by one of Waterloo’s Ethics Committees. The REA is a member of these research ethics committees and independently conducts delegated reviews on behalf of the committees. In accordance with national, provincial, and institutional guidelines and regulations the research ethics review process at Waterloo is overseen by a team of staff in the ORE who work in conjunction with the Human Research Ethics Committee (HREC), the Clinical Research Ethics Committee (CREC) and the Animal Care Committee (ACC). The ORE staff and the Committees operate to fulfil the University’s responsibilities for human participant research and the use of live, non-human vertebrate animals (hereafter referred to as animals) in research and teaching. The ACC is also responsible for ensuring the quality and operation of the animal housing facilities are technical support services provided to researchers on campus. The Ethics Committees are constituted sub-committees and report to the Senate Graduate and Research Council. The two advisory committees; the Research Ethics and Integrity Advisory Committee (REIAC) and Central Animal Facility Advisory Committee (CAFAC) identify emerging lines of research in each of the faculty areas which aid the ethics committees to better anticipate and investigate the ethical implications associated with these types of research well before the committees receive an application.

Key Accountabilities:

1.  Facilitate and conduct ethical analysis of research

 

Applies procedures for effective monitoring of animal purchases with UWaterloo Purchasing office.

 

 

 

2.  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.

 

 

3.  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

 

4.  Demonstrate business knowledge

 

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

 

6.  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)

 

Position Requirements

Education:

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’ experience in ethics administration.

Experience:

3 to 7 years’ 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) 

Technical:

MS Word Excel PowerPoint Other

Microsoft Word at basic level (Lynda.com Word 365)

Microsoft Excel Basic (Lynda.com Excel 365)

 Microsoft Excel Intermediate (SEW 092)

Microsoft Powerpoint at basic level (Lynda.com Powerpoint 365)

Sharepoint at basic level (SEW 090)

 Outlook at basic level (Lynda.com Outlook 365)

 Prior use of an online, web based system

Nature and Scope

Interpersonal Skills:

Excellent written and verbal communication skills (e.g., OHD Business Communications Certificate  Experience in a customer service role (e.g., OHD Inclusivity Certificate Demonstrated ability to plan, prioritize, and manage multiple demands and high volume (e.g., OHD Leadership Essentials Certificate Ability and flexibility to apply established procedures to individual situations (e.g., CETL Supervisory Certificate  Proven ability to deal with confidential materials and information (e.g., Performance Conversations (OHD 305) (Recommended) 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. Courses: Exceptional Service (OHD 301) and Conflict (OHD 603) AND OHD Business Communications Certificate AND OHD Inclusivity Certificate OR OHD Leadership Essentials Certificate OR CETL Supervisory Certificate.

Level of Responsibility:

Demonstrated ability to plan and carry out the implementation of large projects Independently establish multiple priorities and meet established deadlines with little direction.

Decision-Making Authority:

Demonstrate refined and capable professional judgment based on relevant facts and guidelines; independently make decisions during the ethical compliance review of protocols about non-compliance issues and recommend solutions Assist less experienced researchers and team members with problem solving and developing effective solutions to ethical dilemmas Demonstrate refined and capable professional judgment based on relevant facts and eligibility guidelines

Physical and Sensory Demands:

This job requires a keen attention to detail. The incumbent must have an ability to handle numerous disruptions and occasional situations involving conflict or individuals who may be rude, unreasonable or upset.  Intermittent to prolonged periods of keyboarding to word process documents or enter data.

Working Environment:

Experience working in an academic environment In-depth knowledge of the key research ethics and integrity business processes Broad knowledge of the functional areas and processes within the Office of Research  Basic knowledge of the working of the broader uWaterloo departments Detailed knowledge of relevant uWaterloo and Office of Research policies and procedures on either the human or animal side, general familiarity with other domain Understanding of the distinction between sponsor guidelines, externally mandates compliance obligations and uWaterloo policies General familiarity with research integrity process.