Clinical Research Study Assistant

Position Profile:
**Humber River Health. Lighting New Ways In Healthcare.**

Since opening our doors in 2015 as North America’s first fully digital hospital, we remain unwavering in our belief that we can change the hospital where we work, the community where we live, and the world of healthcare beyond our borders. Serving a community of 850,000 residents in North West Toronto, Equity Inclusivity and active participation in the North West Toronto Ontario Health Team are key initiatives important to our Team. At Humber River Health, we use a custom combination of technology and clinical expertise to rebuild elements of care. We make technology work for staff and physicians; giving them more time to spend with patients, to eliminate inefficiencies, and to reduce the chance of errors. Humber River Health is formally affiliated with both the University of Toronto and Queen’s University and committed to becoming a community academic hospital. Clinical Excellence, Optimizing Care through Technology and Community Connection frame our Research Strategy.

At Humber River Health, we’re not hoping for a renaissance, we are making it happen. As part of our dynamic team, you can lead the way, as we continue our journey towards high reliability care

**Clinical Research Study Assistant**

**Reporting Relationship**:Manager, Research

**Location**:Humber River Health - Wilson Site

**Employee Group**:Non Union

**Duration**: Temporary Full Time (approximately 12 months)

**Responsibilities**:

- Assist in interactions with study participants; e.g., scheduling appointments, administer telephone interviews to collect basic study participant data using established criteria and other administrative functions
- Prepares, receives, sorts and processes clinical research samples/specimens following established procedures and guidelines and in compliance with applicable regulations
- Performs limited testing within scope of qualifications and with appropriate training (e.g. medication history) for research purposes
- Provides assistance to the research team in planning and preparing for research activities as per protocol
- Prepares documents, equipment, supplies, etc. in compliance with the protocol.
- May assist with the collection of medical documents as per approved study protocol and authorized access
- Participates in study team meetings
- Under supervision may collect information about adverse events (AEs), identified in the protocol or investigator brochure.
- May assist in the preparation of submissions to the Research Ethics Board (REB).
- Executes study-related administrative tasks, such as collection and maintenance of regulatory documents, ethics submissions, the maintenance & modification of electronic & paper information filing/retrieval methods, systems and/or formats, performing data abstraction from health records or other sources, as per approved study protocol and authorized access and follow SOPs for quality assurance and to assist in documenting and maintaining documentation
- May assist with simple literature searchers under close supervision.
- As directed, assist in preparing studies for closeout (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).
- Communicates with other research personnel as required for study implementation and routine problem resolution.

**Qualifications**:

- Undergraduate Degree in Health or Science-related discipline required
- Recent 1-2 years clinical and/or professional experience in Research
- Experience in MS Office (e.g. Outlook, Word, Excel, PowerPoint, Access, etc.)
- Fundamental knowledge of research principles and practice, regulations and guidelines, such as ICH/GCP guidelines, Tri-Council Policy, Declaration of Helsinki and FDA CFR and Health Canada TPD, as required
- Knowledge of IATA shipping regulations and basic laboratory procedures, as required

**Why choose Humber River Health?**

At Humber River Health, our staff, physicians, and volunteers are lighting new ways in healthcare. We are proud to be recognized as a part of Greater Toronto’s Top Employers by Mediacorp Canada Inc. We support employees by providing evidence-based leadership and cultivating a culture that consistently wows as a Huron Consulting hospital. We are a member of the Toronto Academic Health Science Network (TAHSN) and are deeply involved in research and academic collaboration. We are dedicated to high-quality patient care and demonstrate our values of compassion, professionalism, and respect.

Attracting and retaining a workforce that represents the diverse communities surrounding Humber River Health, is a priority. We encourage applicants from all equity-deserving groups, including but not limited to, individuals who identity as Indigenous, racialized, seniors, persons living with disabilities, women, and those who identify as 2SLGBTQ.

Applicants will not be discriminated against on the basis of race, creed, sex, sexual orientation, gender