Research Coordinator I Dialysis Research

Research Coordinator I

Dialysis Research at Unity Health conducts clinical research trials involving patients on in-centre and home dialysis, including peritoneal dialysis (PD). We also conduct clinical trials in general nephrology and MCKC populations. Our studies encompass investigational drug trials, quality improvement projects, observational studies, and retrospective studies.

Dialysis Research is currently looking for a Research Coordinator I.

The Research Coordinator I conducts day-to-day coordination and implementation of clinical research activities in nephrology, managing studies from initiation through closeout. This role encompasses regulatory compliance, patient care coordination, data management, and team supervision across interventional trials, observational studies, and retrospective database research involving both quantitative and qualitative methodologies.

Occasional travel to Michael Garron Hospital and satellite site at 45 Overlea Blvd will be required. This is hospital based position with potential for occasional hybrid work arrangements.

**Duties & Responsibilities**:
**Legal & Contract Management (5%)**- Coordinate and review research contracts with sponsors and partners for multi-site studies- Coordinate and review Material Transfer Agreements (MTAs), Data Transfer Agreements (DTAs), Confidentiality Disclosure Agreements (CDAs), subaward agreements, and service provider contracts- Liaise with institutional legal and contracts teams to expedite agreement execution

**Study Activation & Site Management (30%)**- **Site Feasibility**:

- Assess study feasibility by assessing adequate patient population, staff capacity, and resource availability- ** Operational Planning**:

- Conduct operational reviews distinguishing standard of care (SOC) from incremental costs (INC), complete study impact assessments- ** Financial Review**:

- Develop study budgets, perform financial feasibility analyses- ** Site Initiation**:

- Coordinate Site Initiation Visits (SIVs) and ensure protocol readiness- ** Event Adjudication-**
- coordinate with adjudicators to ensure timely review- ** Coordinate**
- with other sites an investigator initiated clinical trial- ** Grant Development & Management (5%)**- Coordinate grant-related documentation and compliance requirements- ** Financial Administration (10%)**- ** Budget Management**:

- Develop budget forecasts, monitor expenditures, and provide financial oversight- ** Invoicing & Cost Recovery**:

- Track invoiceable activities and incremental costs; generate financial invoices- ** Vendor Management**:

- Liaise with sponsors, CROs, and vendors to reconcile costs and recover expenses- ** Visit Tracking**:

- Monitor patient visit schedules, protocol adherence, and associated costs- ** Patient Care Coordination (40%)**- ** Multidisciplinary Collaboration**:

- Coordinate with pharmacy, nurse practitioners, pharmacists, dietitians, social workers, and unit coordinators for all aspects of patient care during study participation- ** Patient Visits**:

- Conduct screening, informed consent processes, vital sign assessments, adverse event (AE) collection, and concomitant medication (ConMed) documentation- ** Data Management**:

- Complete Case Report Forms (CRFs), manage Electronic Data Capture (EDC) systems, process and ship biological samples per protocol specifications- ** Safety Monitoring**:

- Identify, document, and report SAEs according to protocol and regulatory timelines- ** Data Management & Analysis (10%)**- Perform data entry and query resolution using REDCap, Medidata, and other EDC platforms- Assist with data analyses for manuscript preparation and presentations- Ensure data integrity, accuracy, and completeness through ongoing quality checks- Support qualitative and quantitative research methodologies as required

**Qualifications**:

- Undergraduate Degree and 2 years of relevant experience, OR demonstrable equivalent combination of specialized education and experience.

- Health Canada Division 5 is preferred (Completed within first 2 weeks of hire)- TCPS CORE 2 is an asset (Completed within first 2 weeks of hire)- Good clinical practice certificate is an asset (Completed within first 2 weeks of hire)- RCR (Responsible conduct of Research) is an asset- Phlebotomy workshop/certificate or lab tech course is an asset- SOCRA is an asset- Clinical Research certificate is an asset

- Basic understanding of science, including applicable theories, frameworks, and models.- Project coordination skills.- Experience with consenting study participants is required- Experience in conducting clinical trials is required- Knowledge of Healthcare research.- Experience with plain language writing is an asset.- Experience working with a diversity of stakeholders is an asset.- Knowledge of applied research.- Quantitative research experience.- Qualitative research experience.- Experience with technical writing.- Basic computer skills with Microsoft Office experience