Lisa Johnston, BScN, CCRP

● ***-** Redpath Ave., Toronto, ON M4S 2J8 ● 647-***-**** ● acvrqf@r.postjobfree.com SKILLS & HIGHLIGHTS

Experienced presenter at academic and professional seminars and conferences.

Development and implementation of clinical research training including GCP, Informed Consent, Adverse Event Management, Medical Device ISO 14155, in-house monitoring program and SOP training

Development and implementation of a competency framework for clinical research personnel and training

Development and implementation of e-learning training sessions

Over 17 years of clinical research experience

EDUCATION

Bachelor Science of Nursing ● Laurentian University ● 1984 ADDITIONAL PROGRAMS & COURSES

Foundations of Project Management ● University of Toronto ● June 2010 Successful Training Manager Workshop ● Langevin Learning Services ● April 2009 Clinical Research Training Course ● Ottawa Hospital Research Institute ● October 2008 Project Management Workshop ● University Health Network ● March 2008 Clinical Trials Management Courses ● University of Western Ontario ● 2003-5 Neuroscience Nursing Program ● The Toronto Hospital ● 1994 Physical Assessment Course ● Humber College ● 1988 PROFESSIONAL EXPERIENCE

March 2015 to Manager, Research Practice

Present Centre for Addiction & Mental Health, Toronto, Ontario

• CAMH project lead for the implementation of the new CAMH Clinical Research Approval System

• Oversee research personnel credentialing, development and qualifications, development and provision of training programs/toolkits, and management responsibilities in alignment with the Research Strategic Plan

• Provide support to researchers and staff in compliance with regulatory requirements and advancing the strategic research goals of CAMH

• Support the CAMH research community, academic colleagues and CAMH research stakeholders through education, training, professional practice requirements and other resources that enhance research participant well-being and data quality

• Manage the casual RN pool for research

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May 2011 Research Training Coordinator

- March 2015 Centre for Addiction & Mental Health, Toronto, Ontario

• Developing education strategies for research staff and investigators to meet regulatory and CAMH polices requirements

• Collaborate with department members and SME to design, develop and implement training programs

• Develop and maintain all course documentation

• Develop and maintain online learning

• Monitoring and evaluating the effectiveness of training program

• Tracking research training

• Providing new research hire orientation

• Deliver education consultation services and support to research staff including coordinating the development and administration of SOPs with research

• Play a key communications role by developing communication and training strategies for implementation of SOPs and policies

• Assist in the development of Research Regulatory Training intranet site

• Develop and update CAMH Institutional Research SOPs in consultation with SME, Director, Quality Assurance and Director, Research Services

• Develop and update applicable Research policies

• Develop SOPs for monitoring investigator-initiated studies in consultation with SME, Director, Quality Assurance and Director, Research Services

• Providing training on monitoring SOPs as required

• Monitor investigator-initiated studies as delegated. October 2008 - Manager, Clinical Research Practice Department May 2011 University Health Network, Toronto, Ontario

• Responsible for the development and implementation of education and training sessions for Clinical Research Personnel

• Act as a resource to clinical research personnel and Principal Investigators

• Lead clinical research practice projects including communication, training implementation, SOP development for UHN research

• Responsible for the development of tools, guidelines and procedures to enhance efficiency in clinical research compliance

• Identify training needs according to legislative, regulatory, industry and client requirements and through job analysis and regular consultation with stakeholders

• Deployed monthly training sessions, including venipuncture training, clinical research safety training, budget workshops, informed consent workshops.

• Developed systems for tracking personnel in clinical research and their training compliance

• Manage the department, including staff development and budget 2 of 5

Lisa Johnston

July 2007- Clinical Research Coordinator II

Sept 2008 Clinical Studies Resource Centre

University Health Network, Toronto, Ontario

• Develop and implement education and training session for Clinical research staff (SOP training, GCP training, budget development training, venipuncture training)

• Chair of Clinical Research Collaborative Committee

• Act as a resource to research staff and Principal Investigators

• Develop tools, guidelines and procedures to enhance efficiency of clinical research compliance

• Assist or prepare CTA applications

• Negotiated with external vendors for initial mandatory GCP training

• Audited and monitored (requested) investigator-initiated studies. July 2001 – Clinical Research Coordinator II

June 2007 Dr. A.E. Lang – Movement Disorders Centre Toronto Western Hospital, Toronto, Ontario

April 1999 - Research Coordinator

July 2001 Ottawa Regional Women’s Breast Health Centre (WBHC), Ottawa Hospital – Civic Campus

May 1996 - Clinical Trials Coordinator

April 1999 Dr. A.E. Lang – Movement Disorders Centre Toronto Western Hospital, Toronto, Ontario

May 1984 – Staff Nurse – General Surgery, Oncology, Emergency, Family Medicine, Neurosurgery May 1996 experience

Sudbury and Toronto, Ontario

CONFERENCE PRESENTATIONS

September 20, 2014 ● 23rd Annual Conference ● Mandatory Training Program for Quality Research May 10, 2014 ● SOCRA Conference - Conducting Clinical Trials in Canada ● CAPAs, The Who, What, Where

& When to Use.

October 19, 2011 ● Insight – 13th Edition Clinical Trials in Canada Post Conference Workshop ● The Clinical Trials Budget Process Navigating the Turbulent Waters October 17-18, 2011 ● Insight – 13th Edition Clinical Trials in Canada ● Achieving Excellence in the Conduct of Investigator Initiated Research (IIR)

February 22-23, 2010 ● The Canadian Institute's Managing Legal & Business Risks of Clinical Trials in Canada Conference ● Budgeting for Clinical Trials: The Experts’ Approach 3 of 5

Lisa Johnston

October 18-19, 2010 ● Insight -11th Edition Clinical Trials in Canada ● Financial Management in Clinical Trials Latest Tools and Strategies

September 12, 2009 ● An Integrated Industry and Academic Conference for Clinical Trials in Oncology ● Informed Consent Session

March 2005 ● Skills Workshop on “The Role of the Movement Disorders Nurse” at the International Movement Disorders Congress on Parkinson Disease and Movement Disorders, New Orleans, Louisiana.

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OTHER PRESENTATIONS

January 2015 – GTA SOCRA Chapter Meeting Presentation: Optimizing the Informed Consent Discussion

(by ensuring that participants can read and understand what is in the inform consent form) Yearly Guest speaker (2009 to present) - University of Toronto, Department of Health Policy, Management and Evaluation Course: HAD 5310H Pragmatic Issues in Conduct of Controlled Trials – Topic – Budget Management and Negotiations in Clinical Research

November 2005 ● Krembil Neuroscience Presentation at Toronto General on “Challenges of Pediatric Movement Disorders Patients in an Adult Setting”, September 2004 ● Presentation to the Sudbury Parkinson’s Disease Support Group on “Coping with Parkinson’s Disease

June 2002 ● Parkinson’s Disease and Psychiatric Issues. Neuroscience Interdisciplinary Inservice, ● Toronto Western Hospital,

May -1999 to June 2001 ● Workshops/Presentations to Ottawa Region Support Groups/Health Professionals on Breast Cancer Prevention –

September 1999 ● Prevention Workshop for Health Professionals, Discovery International, ● Ottawa, Ontario May-November 1998 ● New Treatments in Parkinson’s Disease for the Parkinson Support Groups 1996 ● Preoperative and Postoperative Concerns of Craniotomy Patients for Brain Tumour ● Presented at the American Neuroscience Nursing Conference and the Canadian Neuroscience Nursing Conference PUBLICATIONS

MA Schwarzschild, SR Schwid, K Marek et al and the Parkinson Study Group PRECEPT Investigators. Serum Urate as a Predictor of Clinical and Radiologic Progression in Parkinson Disease. Arch Neurol 2008; 65(6): E1-8.

AJ Espay, YY Li, L Johnston, R Chen, AE Lang. Mirror movements in parkinsonism-evaluation of a new clinical sign. J Neurol Neurosurg Psychiatry 2005; 76(10): 1355-1359. 4 of 5

Lisa Johnston

J.G. Nuttet, K.J. Burchiel et al and the ICV GDNF Study Group. Randomized, double-blind trial of glial cell line- derived neurotrophic factor (GDNF) in PD. . Neurology 60, January (1 of 2) 2003 Jan Duff and Lisa Johnston. Should you participate in clinical trials? Parkinson Post. Winter 2002, Volume 2, Issue 4.

Lisa Johnston. Dissemination of Information for Newly Diagnosed People with Parkinson’s – How are we doing? Circular in Motion Newsletter. Fall 2002, Volume 5.1 Dawn Stacey, Cathy DeGrasse and Lisa Johnston. Addressing the Support Needs of Women at High Risk for Breast Cancer: Evidence-Based Care by Advanced Practice Nurses. Online Exclusive. ONF – Volume 29, No. 6, 2002

Parkinson Study Group (de Marcaida JA, primary author). Evaluation of dyskinesias in a pilot, randomized, placebo-controlled trial of remacemide in advanced Parkinson disease. Arch Neurol 2001;58:1660-1668. Parkinson Study Group. A randomized, controlled trial of remacemide for motor fluctuations in Parkinson’s disease. Neurology, 2001; 56: 455- 462.

Peter Hagell, Peggy Gray, Yvonned Jansson, Lisa Johnston, Carol Moskowitz, Elke Rost-Ruffner. An Introduction to Movement Disorders for the Neuroscience Nurse. Canadian Movement Disorder Newsletter. Spring 1999.

Peter Hagell, Peggy Gray, Yvonned Jansson, Lisa Johnston, Carol Moskowitz, Elke Rost-Ruffner.An Introduction to Movement Disorders for the Neuroscience Nurse. International Brain Wave. May 1998. POSTER PRESENTATION

Stephen Giles M.S.W, RSW. Lisa Johnston B.ScN, RN. Connie Marras MD, PhD. FRCPC. Biopsychosocial Needs Assessment of Persons Living with Parkinson Disease and their Family Caregivers. Presented at the International Movement Disorders Congress May 30, 2007 in Turkey, the National Parkinson Foundation Conference October 20, 2007 in Miami, and UHN Allied Health Research Day January 2008. PROFESSIONAL MEMBERSHIPS

Clinical Research Association of Canada (CRAC) – (April 2012 to 2014) College of Nurses of Ontario – Registration # 84-3626 3 (1984 to present) Registered Nurses of Ontario – (1999 – present)

Society of Clinical Research Associates (SOCRA) – (2003 – present) COMMITTEES

Network of Network (N2) Member – 2007 - present

• Education Committee – 2008 – present

• Co-Chair – 2013 - present

• GCP lead – 2013 - present

CAMH Research Quality & Risk Committee – 2012 - present 5 of 5

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