Trial Activation Coordinator (GEN)

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 Excellence in Diversity and Inclusion Award, from the Canadian College of Health Leaders, for our work led by the Organizational Development and Diversity Department on our Leading edge Communities of Inclusion, Inclusion Calendar and our innovative Health Equity Certificate programs. We are also proud to be named Canada’s Most Admired Corporate Cultures for 2023! Learn more at shn.ca

Job Description:

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.

Job 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

Qualifications:

• 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

Assets:

• PMP (Project Management Certificate)

• Transportation of Dangerous Good (TDG/IATA) certification

• Phlebotomy

• CCRP

Accommodation and Diversity Statement:
Scarborough Health Network (SHN) embraces and celebrates our community’s unique multicultural heritage and diversity. SHN is an equal opportunity employer, dedicated to a culture of inclusiveness and diversity reflecting our diverse patients, staff and community alike.
We are committed to fostering an environment of equity and inclusivity where every person can work and receive care safely, openly and honestly. All qualified applicants will receive consideration for employment without regard to race, colour, religion, gender, gender identity or expression, sexual orientation, nation of origin, genetics, disability, age, veteran status, marital or family status, belief system, or other factors related to one’s personal identity and/or values.
We are committed to providing barrier-free and accessible employment practices in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Should you require accommodation through any stage of the recruitment process, please make them known when contacted and we will work with you to meet your needs.

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