Trial Activation Coordinator (GEN)

Scarborough Health Network

1d•$40 - $46•Onsite

About The Position

Across our three hospitals and eight satellite sites, Scarborough Health Network (SHN) is shaping the future of care. Our many programs and services are designed around the needs of one of Canada’s most vibrant and diverse communities. We are home to North America’s largest nephrology program, as well as the designated cardiac care and spine centre for Scarborough and surrounding communities to the east. We are proud to be a community-affiliated teaching site for the University of Toronto and partner with a number of other universities and colleges, helping to train the next generation of health care professionals. SHN is the recipient of the 2021 Excellence in Diversity and Inclusion Award, from the Canadian College of Health Leaders, for our leading edge work on Communities of Inclusion, Inclusion Calendar, Health Equity Certificate Program and much more. We are also proud to be named Canada’s Most Admired Corporate Cultures for 2023 and 2024! Learn more at shn.ca Company Overview: The Scarborough Health Network Research Institute (SHNRI) is dedicated to supporting SHN researchers and their teams in achieving their research goals. In this job, you will perform and support research activities at SHN under the direction of the SHNRI and principal investigators for research studies. The RI provides the necessary oversight and guidance to ensure regulatory compliance, grant administration, and quality control in study conduct. They will work with various internal and external stakeholders including Investigators, Coordinators, Sponsors, Research and Clinical Teams to assist with the daily operations of clinical research studies. Position Overview: This role will have a particular focus in industry sponsored study start up: such as contract negotiations, feasibility, Informed Consent development, and REB submission. This role can also include participant recruitment, study documentation, collection and maintenance of data, invoicing and financial account reconciliation, and general RI administrative duties. They will be required to utilize their knowledge of research principles and practices to coordinate aspects of the project. The individual must abide by and adhere to hospital and RI policies and procedures with regards to various sources of information such as health records and databases and maintain the confidentiality of patient files and study data. This role will primarily be focused at Scarborough General Hospital and on the rare occasion travel between sites may be required.

Requirements

Undergraduate Degree in Health or Science related field
3-4 years of clinical and / or professional experience with at least 2 years of clinical research experience, preferably with industry sponsored trials e.g. could have been a Data Coordinator, CRCI or CRCII prior
Advance knowledge / certifications in the following
Tri-Council Policy Statement (TCPS 2)
Health Canada Division 5
ICH-GCP
Declaration of Helsinki
Advanced skills in: Study start-up activities such as: set-up and maintain study documents and folders, preparation of REB submissions, assist with contracts and finance related paperwork
Strong project management and/or trial coordination skills
Experience with Patient Screening and Informed Consent process and Clinical Trial Recruitment
Ability to prepare and assist during the conduct of auditing, monitoring and inspection visits
Ability to perform clinical tasks, as trained and delegated, by PI/Management and noted in Protocol and source/CRF/eCRF e.g. vitals, AE data collection and reconciliation

Nice To Haves

PMP (Project Management Certificate)
Transportation of Dangerous Good (TDG/IATA) certification
Phlebotomy
CCRP

Responsibilities

Project manage all industry sponsored trials in start-up; create project plan and execute
Set-up and maintain study documents and folders within the SHNRI SharePoint site
Lead Site Qualification Visits (SQV) and Site Initiations Visits (SIVs)
Conduct feasibility; work with internal SHN departments to coordinate how the trial will be executed
Preparation of REB submissions and liaison with REB
Assist with contracts and finance related paperwork
Provide research administrative support for studies/projects
Troubleshoot problems at all stages of project development and implementation and assist with modifying project procedures to address challenges
Initiate, manage and maintain archiving and retrieval process of study records as per regulatory requirements
Lead RI administrative tasks such as, responsible for general RI inbox, SharePoint sites, office supply ordering
Aid in onboarding students and volunteers
Aid Manager in developing SOPs, procedures, checklists and SBARs
Invoicing and financial account reconciliation
Organize and perform participant recruitment (including screening and informed consent process) and study activities
Perform collection, transcription and entry of study related data
On the rare occasion perform clinical tasks as trained and delegated to, and noted in Protocol e.g. perform specific medical procedures such as, venipuncture, pipetting samples, administering medication by injection, monitor patients for adverse reactions and be prepared to respond appropriately.
Collaborate with CRC’s, PI and his / her clinical team to execute study clinical requirements and coordinate with follow-up visits and clinical care
Under supervision of Management and as directed – prepare and assist during the conduct of auditing, monitoring and inspection visits

Benefits

Defined Benefit pension plan through the Healthcare of Ontario Pension Plan
Comprehensive insured benefits package including health and dental benefits
New Graduate Initiative
Enroute Program
Critical Care Sponsorship Program
Employee Discount and Incentive Programs
Employee and Family Assistance Program (EFAP), along with other comprehensive wellness offerings, including our Spiritual Care team of registered psychotherapists for spiritual, religious or emotional care; mental health supports; and on-site wellness rounding
Recognition events
Leadership Development and Learning Programs
Tuition Assistance Program