Clinical Research Study Assistant

Job Number: JR103692

Job Title: Clinical Research Study Assistant

Job Category: Student

Hospital Location: General Site

**Job Type**: Temporary (Fixed Term), Full time

Contract Duration: 13 months

Number of Positions: 1

Union:
Minimum - Maximum Hourly Rate: $29.32 - $33.99

Hours: Days, Afternoons

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:
Position 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 Critical Care studies and research activities at SHN under the direction of the SHNRI and principal investigators for research studies. The research assistant provides the necessary oversight and guidance to ensure regulatory compliance, grant administration, and quality control in study conduct.

Job Responsibilities:

- Supports the preparation and organization of regulatory documents, delegation logs, and study binders
- Schedules and prepares for Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), and overall study logistics
- Ensure SHNRI SharePoint is up to date with all study documents to foster collaboration
- Performs data entry into Case Report Forms (CRFs) from health records and source documents as per protocol
- Resolves data queries with mínimal supervision
- Prepares, receives, sorts and processes clinical research samples following established procedures and in compliance with applicable regulations
- Provide support and assistance to the study team in preparing environment for conducting research activities as per protocol
- Tracks approval timelines and ensures proper documentation is maintained
- Aid PI’s in setting up finances for their studies
- Interact with study participants e.g., scheduling appointments, informed consenting for low-risk trials, and other general Research Institute administrative functions
- Other duties as required

Qualifications:

- Undergraduate degree or college diploma in health-related studies
- Patient screening and informed consent process experience
- Data input; experience using different Sponsor/ Clinical Research Organization (CRO) platforms e.g. REDCap, Medidata
- Familiarity with medical terminology
- Proficient with Microsoft Office Programs such as MS Teams, SharePoint and Word
- Great in person and telephone communication skills, including the ability to accurately summarize and communicate information
- Good time management, organizational skills and ability to prioritize multiple competing demands
- Ability to work independently as well as in a multi-disciplinary team

Assets:
Certifications in the following:

- Tri-Council Policy Statement (TCPS 2)
- Health Canada Division 5
- Canada GCP
- Transportation of Dangerous Goods (TDG/IATA)
- Phlebotomy
- CCRP

Knowledge of the following:

- Declaration of Helsinki
- Clinical Trial Recruitment
- REB submission process
- Grant writing, review and administration
- Preparation and assistance experience during the conduct of auditing and inspection visits
- 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 Ac