Clinical Research Study Assistant

Salary Range

$65,442.00-$81.855.15Reporting Relationship: Manager, Research

Responsibilities

Study Coordination & Compliance: 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. Performs limited testing within scope of qualifications and with appropriate training (e.g. medication history) for research purposes. Prepares documents, equipment, supplies, etc. in compliance with the protocol. Provides assistance to the research team in planning and preparing for research activities as per protocol. Prepares, receives, sorts and processes clinical research samples/specimens following established procedures and guidelines and in compliance with applicable regulations. Patient Recruitment & Retention: Screen, recruit, and enroll eligible study participants following inclusion/exclusion criteria. Obtain informed consent from study participants and ensure understanding of study procedures. Schedule and conduct study visits, ensuring adherence to protocol requirements. Data Collection & Management: May assist with the collection of medical documents as per approved study protocol and authorized access. Under supervision may collect information about adverse events (AEs), identified in the protocol or investigator brochure. Regulatory & Documentation Management: 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. Communication & Collaboration Participates in study team meetings. Communicates with other research personnel as required for study implementation and routine problem resolution. May assist in the preparation of submissions to the Research Ethics Board (REB). 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). Other duties as assigned

Qualifications

Education & Experience: Undergraduate Degree in Health or Science-related discipline required. Recent 1-2 years clinical and/or professional experience in Research. Skills & Competencies: 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 with our unwavering commitment to Staff, Physician and Volunteer engagement. 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. Humber River Health is committed to creating an inclusive, equitable and accessible workplace that reflects the diversity of our communities. Guided by our strategic direction to embed equity, diversity and inclusion in everything we do – and to address systemic barriers – we foster a culture where everyone feels respected, valued and empowered to contribute. We welcome applications from individuals of all equity-deserving groups, including Indigenous peoples, racialized communities, persons living with disabilities, women, 2SLGBTQ+ individuals and seniors. We recognize that diverse identities and perspectives strengthen our ability to deliver safe, innovative and compassionate care. As an equal opportunity employer, Humber River Health complies with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. We do not discriminate on the basis of race, ancestry, place of origin, colour, ethnic origin, citizenship, creed, sex, sexual orientation, gender identity or expression, age, marital status, family status, disability, or any other protected ground. Accommodations are available throughout the recruitment process and employment. Please contact our recruitment team to discuss your needs confidentially. This position is being posted in response to an existing vacancy at Humber River Health. Recruitment Fraud Notice: Humber River Health does not request fees or payment from applicants as part of the recruitment process. If you receive suspicious recruitment-related advertising, communication, or content that does not appear to come from Humber River Health, please report it to hr@hrh.ca with any relevant details, screenshots, or links.