Danica Nogo

• Under the supervision of Director and PI of the Movement Disorders Clinic: Anthony Lang, OC, M.D., FRPCP, FAAN, FCAHS, FRSC and Connie Marras, M.D., PhD., FRCPC

Clinical Research Responsibilities:

• Coordinates all aspects of clinical trials and research studies, including:
• Develop, implement, and maintain high quality clinical trial procedures and processes
• Train clinical research and trials staff
• Research ethics board (REB) applications, renewals, and amendments
• Liaise with investigators, administrative staff, sponsors, CRO, and clinical trials staff
• Develop and amend budgets for clinical trials and research projects
• Develop and amend CTAs and study sub-agreements with third parties
• Recruitment of study participants (e.g., identification/screening, obtaining of consent, etc.)
• Coordinates all aspects of clinical trial visits - including nursing and physician assessments, physiotherapy assessments, EKG, biospecimen acquisition and handling, electrophysiological testing, and respiratory measurements
• Performs vital signs (blood pressure, temperature, pulse oximetry, respiration rate), electrocardiograms (ECG), subcutaneous injections, ventipuncture, and other medical procedures
• Planning, review, implementation and coordination of data collection and source documentation, as per UHN policy and ICH/GCP guidelines
• Collects study data from participants or other sources in support of clinical and study-related decision-making, using pre-defined data collection tools (e.g., administering questionnaires, completing study worksheets, etc.) as per approved study protocol and authorized access
• Assists in coordination of research participant visits and schedule as per study protocol
• Ensures compliance with monitoring visits
• Prepares for monitoring visits and audits
• In-clinic EPIC Superuser
• Interacts with participants to facilitate the completion of required research activities as per protocol and in collaboration with inter-professional team members, as needed; and exercises their own judgement in analyzing data for assigned research studies
• This may include: planning and participating in mid-level data analysis; drawing conclusions for review and incorporation into final research reports; assisting in the interpretation of results and the preparations of material for presentation, publication and/or grants; and performing administration tasks related to the study

• Under the supervision of Directors and PIs of Neuromuscular Research Centre: Jodi Warman, Chardon, M.D., MSc., FRPCP and Ariel Breiner, M.D., MSc., FRPCP

Clinical Research Responsibilities:

• Coordinates all aspects of clinical trials in neuromuscular disease, including:
• Research ethics board (REB) applications, renewals, and amendments
• Planning / design of study budgets
• Participant screening, pre-screening, recruitment, and consenting
• Coordinates all aspects of clinical trial visits - including nursing and physician assessments, physiotherapy assessments, EKG, biospecimen acquisition and handling, electrophysiology testing, and respiratory measurements
• Quantitative data collection including participant questionnaires, functional assessments, and telephone follow-ups
• Performs vital signs (blood pressure, temperature, pulse oximetry, respiration rate), electrocardiograms (ECG), subcutaneous injections, venipuncture, and other medical procedures
• Performs in-house screening diagnostics, such as drug screen panels
• Data entry using a variety of database software, including EDC
• Compliance with monitoring visits
• Maintenance of study finances and accounting
• Prepares, processes, and shipment of lab samples and human biospecimens (ambient and frozen - dry ice)
• Processes study samples as per protocol requirements, and packages samples for shipment to the appropriate clinical diagnostic or analytical laboratory (Intra-Canada, International)
• Prepares study related materials, such as labeling of study tubes, and preparation of clipboards, and ensures availability of clinical trial supplies
• Calibrates and maintenance of equipment per SOPs and maintains appropriate logbooks
• Assists in set-up and maintenance of laboratory, study supplies, equipment, and IP
• Provides support to adults affected by neuromuscular disease
• Trains new hires and other research staff members
• Reports to the principal investigators, liaises with other research staff
• Serves as a liaison to physicians, principal and co-investigators, patients and other staff members regarding the research process and individual protocols
• Serves as primary contact for multiple clinical trial studies or sites
• Participates in meetings and conference calls as required

• Under the supervision of Director of Centre for Clinical Neuroscience: Flávio Kapczinski, MSc., M.D., PhD., FRPCP

Clinical Administrative and Research Responsibilities:

• Provides support to senior researcher within the Mood Disorders Program in the Department of Psychiatry and Behavioural Neurosciences, including support to the research team in the development of the Neurosciences Program
• Helps to facilitate the offer and onboarding of learners, i.e. postdoc fellows and research assistants
• Provides administrative assistance in arranging travel, accommodations and organizing seminars and conferences
• Financial management of the various research programs and funding, and assist the faculty member with OHIP billings and academic work
• Monitors budgets, reconciles accounts, and develops financial projections
• Writes a variety of documents such as correspondence, procedure manuals, reports, and minutes
• Plans and coordinates a variety of events and activities such as conferences, seminars, and workshops
• Establishes priorities for general office operations
• Utilizes discretion and judgment to screen visitors and telephone calls, and notify appropriate personnel
• Greets visitors, answers or redirects general inquiries in person, by telephone and via email and respond independently to inquiries that are specific in nature and require a thorough knowledge of established policies and procedures
• Completes financial forms such as travel expense reports, electronic cheque requisitions, purchase orders and journal entries
• Conducts database, literature, and web searches to find references and articles used for a variety of documents, reports, and publications
• Provides policy and procedure information to others
• Gathers and compiles the paperwork required to facilitate hiring and payment processes
• Collects, verifies, and inputs data into a variety of spreadsheets and databases
• Coordinates the calendar of supervisor and others and resolves scheduling conflicts
• Writes a variety of formal notes and records such as meeting minutes
• Updates and maintains information on websites and social networks
• Formats, word processes, edits, and proofreads a variety of documents and materials
• Applies standard mathematical skills such as calculations, formulas, and equations to perform a variety of calculations
• Monitors and orders office supplies
• Sources and obtains pricing information for office supplies and equipment
• Sets up and maintains filing systems, both electronic and hard copy
• Classifies, sorts, and files correspondence, records, and other documents
• Updates and maintains confidential files and records
• Handles sensitive material in accordance with established policies
• Assembles, copies, collates, and disseminates a variety of documents and materials

• Under the supervision of Head of the Mood Disorders Psychopharmacology Unit: Roger S. McIntyre, M.D., FRCPC

Clinical Research Responsibilities:

• Monitors progress and provides updates on project-related tasks to supervisors
• Coordinates and manages research teams, including correspondences between team members and supervisors, maintains meeting minutes, delegation of tasks, and establishes timelines for projects
• Conducts literature searches, reviews, methodology
• Data analyses (including qualitative and quantitative analysis)
• Creates, inputs and reviews databases using IBM SPSS
• Monitors patient study logs, including current and past medications history
• Writes manuscripts and study protocols
• Manuscript submission for publication
• Attends weekly team meetings to discuss clinical studies, publications, and trends

• Under the supervision of Clinical Director: Martin A. Katzman, BSc., M.D., FRCPC

Clinical Research Responsibilities:

• Recruits participants, conducts telephone interviews, and administers questionnaires
• Collects and enters data from phone interviews
• Prepares and transcribes patient Mini-International Neuropsychiatric Interview (MINI 7.0) and consult assessment reports
• Inputs and reviews databases using IBM SPSS
• Performs literature searches using PubMed, MEDLINE, or other health sciences databases
• Prepares presentations, manuscripts, and methodology verification
• Reviews grant eligibility and processing
• Maintains references using referencing software (e.g. Mendeley, Zotero)
• Patient case work

Fulcrum Therapeutics, 2019-2022
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 24-Week, Parallel-Group Study of the Efficacy
and Safety of Losmapimod in Treating Subjects with Facioscapulohumeral Muscular Dystrophy (FSHD)
Clinical Trial Name: FIS-002-2019

WinSanTor, Inc., 2019-2022
A Randomized, Double-Blind, Placebo-Controlled, Parallel, 24-Week, Phase 2a Study of Topical Pirenzepine
(WST-057) or Placebo in Type 2 Diabetic Patients with Peripheral Neuropathy
Clinical Trial Name: WST-PZP-002

University of Calgary, 2019-2022
A Phase II Randomized, Placebo-Controlled, Double-Blinded, Multi-Centre Clinical Trial of Pimozide in
Patients with Amyotrophic Lateral Sclerosis
Clinical Trial Name: Pimozide_ALS-002

Cytokinetics, 2021-2023
A Study to Evaluate Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis
(ALS)
Clinical Trial Name: COURAGE-ALS

Pharnext, 2021-2023
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy, Safety
and Tolerability of PXT3003 in Charcot-Marie-Tooth Type 1A (CMT1A)
Clinical Trials Name: PREMIER (CLN-PXT3003-06)

Janssen Research & Development, LLC., 2021-2023
Efficacy and Safety Study of Nipocalimab IV Infusions for Adults with Generalized Myasthenia Gravis
Clinical Trial Name: MOM-M281-011

Michael J. Fox Foundation, 2021-2036

The Parkinson's Progression Markers Initiative (PPMI) Clinical 2.0 - Establishing a Deeply Phenotyped PD Cohort

Clinical Trial Name: PPMI 2.0

Cerevel Therapeutics, 2021-2023

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-01 Trial)

Clinical Trial Name: TEMPO-01

Cerevel Therapeutics, 2021-2024

58-Week Open-Label Trial of Tavapadon in Parkinson's Disease (TEMPO-04 Trial)

Clinical Trial Name: TEMPO-04

Ottawa Hospital Research Institute, 2018-2022

B3 for NMD: Bench to Bedside and Back Transformative discoveries leading to improved care in Neuromuscular Disease

Clinical Trial Name: B3 for NMD

Ottawa Hospital Research Institute, 2019-2023

A Prospective, Multi-center, Observational Study of the Safety, Tolerability, and Effectiveness of SPINRAZA in Adult Patients with Spinal Muscular Atrophy

Clinical Trial Name: Spinraza

Ottawa Hospital Research Institute, 2019-2022

Understanding Palliative care and End of Life Needs in ALS Population: The First Step to Improving Patient
and Caregiver Quality of Life

Clinical Trial Name: Palliative Care in ALS

study