Research Coordinator Ii Research Options Lab

7 months ago

Toronto, Canada Unity Health Toronto Full time

Specific tasks will include preparing submissions for research ethics, creating and maintaining study records, recruiting study participants, conducting study visits as per protocols, collecting and processing samples as appropriate, and maintaining meticulous study records in compliance with study protocols and Health Canada regulations. These tasks require excellent project management, interpersonal communication, and knowledge of Good Clinical Practice guidelines, Health Canada Division 5 regulations and TCPS2. Prior familiarity with HIV research and principles of community-engaged research are an asset.

This position is onsite with the option for occasional remote work.

**Duties & Responsibilities**:
**Research Duties (50% of work time)**
- Ongoing coordination of study activities; day to day project management of timelines, resources, deliverables, and study tasks.
- Assists Principal Investigator and Research Program Manager in the initiation of new research and:
- Coordinates and conducts screening, recruitment, and follow-up visits with participants.
- Manages, prepares, and oversees monitors/audits.
- Monitors, and controls research regulations, quality, and guidelines, including ethical (e.g., REB submissions), and safety protocols.
- Writes and administers informed consent forms.
- Participates in quantitative and qualitative data collection, including conducting interviews, data entry, cleaning/coding data, and quality control, in accordance with hospital and privacy regulations.
- Prepares and presents research related information in consultation with multiple stakeholders, including reports, proposals, publications, manuscripts, abstracts, newsletters, posters etc.
- Conducts and may lead study assessments and reports, literature reviews, data analysis etc.
- Contributes to the interpretation and implementation of project goals, protocols, and plans (including risk management).
- Creates evidence-based solutions, efficiencies or high-level plans when necessary.
- Develops processes, tools (workflow, Gantt charts), and resources to support team members, and projects.
- Provides logístical support in collaboration with funding partners, confirms and maintains budgets.
- Manages, oversees, and coordinates research activities for PI and sponsor initiated research including:

- Ensuring appropriate contracts are in place.
- Responding to REB queries and ensuring approvals are in place.
- Facilitates shipment of investigational devices to clinical trial sites.
- Provides project management support and oversight to research staff in other research sites and research assistants.
- Prepares invoices and reimbursements and works with research finance to issue payments.
- Manages honoraria, ensuring signatures for each participant.
- Biological sample collection (Phlebotomy, dry blood spot testing etc.), processing and shipping according to TDG/IATA.
- Maintains awareness of health and research news, events and current high-profile research activities.

**Administrative Duties (35% of work time)**
- Designs source documents (templates, tracking files, forms, guidance documents) for the collection, and management of information/data.
- Creates trainings, manuals, e-learning content for clinical trial conduct
- Organizes, facilitates, and runs meetings with internal teams, and external stakeholders.
- Negotiates budgets with external and internal stakeholders.
- Prepares reports for funding agencies, and other internal or external stakeholders.

**Day to day project and staff guidance (15% of work time)**
- Coordinates, trains, mentors, and delegates tasks (including overseeing quality control of submitted assignments) to Research Assistants, volunteers, students, casual staff, internal/external collaborators, and Research Coordinator I's.
- Assists with hiring and onboarding new staff and supports team members through capacity building, and coaching.
- Supports team growth and encourages collaboration and team-focused approaches through participation in team meetings and education sessions.
- Completes Health Canada regulatory inspections for regulated clinical trials and supports the institution and the investigator in maintaining compliant practices.

**Performs cross functional and other duties as assigned and/or requested.**

**Qualifications**
- Undergraduate Degree and 3 years of relevant experience, OR demonstrable equivalent combination of specialized education and experience.
- Experience in clinical research is required.
- GCP certificate is required. (Completed within first 2 weeks of hire)
- Health Canada Division 5 certificate is required. (Completed within first 2 weeks of hire)
- TCPS CORE 2 is required. (Completed within first 2 weeks of hire)
- Clinical Research certificate is an asset.
- Completion of or willingness to complete a phlebotomy workshop/certificate or lab tech course is an asset.
- Familiarity with medical/healthcare terminology.
- Understanding of systemic power structur

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