Clinical Research Coordinator

**The Ottawa Hospital: Inspired by research. Driven by compassion**
The Ottawa Hospital Research Institute is the research arm of The Ottawa Hospital and an affiliated institute of the University of Ottawa. With more than 1,700 scientists, clinician investigators, trainees, and staff, and total revenues of more than $100 million, we are one of the foremost Canadian hospital-based research institutes. We are investigating virtually every major disease and condition, with a focus on answering important health questions and translating our findings into benefits for patients and society.

Dr. Daniel McIsaac is an anesthesiologist and scientist at The Ottawa Hospital and a CIHR-funded investigator. As team lead for the Aging Innovation in Perioperative Medicine & Surgery (AIMS) Research Group, Dr. McIsaac’s research program at the Ottawa Hospital Research Institute looks to improve the care and outcomes of older people who require major surgery with a special focus on frailty, health system performance, and patient-reported outcomes. AIMS is an interdisciplinary team of motivated researchers, clinicians, research staff, patient partners, and trainees who work in a collaborative and team-based environment.

**Job description**
Under the supervision of Dr. Daniel McIsaac and the team’s Clinical Research Associate, the Clinical Research Coordinator will help support two CIHR-funded, investigator-initiated clinical pilot trials to improve the outcomes of adults having surgery. These pilot trials will be launched in a staggered fashion (i.e., Study 1 is already in the start-up phase and will launch before Study 2).

Study 1: A vanguard pragmatic multicenter randomized trial of Structured Training to Improve fitness in a Virtual Environment: The STRIVE Before Surgery Trial. The STRIVE Before Surgery Trial is an investigator-led, Randomized Controlled Trial (RCT) of a virtually-supported home-based rehabilitation program including exercise and nutrition versus standard care for adults preparing for elective inpatient surgery. The AIMS research group will be the coordinating center with 2 participating sites in Ontario.

Study 2: The Anesthesia for Lower limb revascularization to Optimize Functional OuTcomes (ALOFT) Trial: a pilot multicenter randomized trial. The ALOFT Trial is an investigator-led feasibility pilot trial at 3 hospitals in Ontario. This trial is testing anesthesia type (general anesthesia versus spinal/epidural) for improving patient-reported outcomes for adults having lower limb revascularization surgery. The AIMS research group will be the coordinating center with 2 participating sites in Ontario.

Responsible for the oversight and execution of local study start-up activities in accordance with the study protocol and applicable research regulations. Activities include but are not limited to, developing local study procedures (screening, consent methods, data collection procedures, etc.), creating the investigator study file, training study staff, etc.
- Collaborate with different departments and teams to establish effective processes to properly execute the study protocol. For example, work with Project Fusion and The Ottawa Hospital’s Pharmacy Department to formalize a process for investigational product ordering and fulfillment in EPIC.
- Establish dynamic and effective participant identification, screening, and referral procedures both locally and at participating sites.
- Create and organize all required participant-facing (informed consent forms, data collection tools, intervention materials, etc.) and internal study documentation (Master Log, Screening Log, team calendars, etc.).
- Work with the local study team and graphic designer to oversee the creation of professional study advertisements and promotional materials (study website, posters, brochures, etc.).
- Draft and formalize trial standard-operating procedures, including the creation of any guidance or supporting documents required by the study team.
- Establish an electronic database through REDCap or the Ottawa Methods Centre’s Electronic Data Capture System that facilitates the collection and documentation of all required trial data (i.e., patient-reported and chart review).
- Manage trial data, including data collection and the identification, documentation, and resolution of any data queries.
- Oversee the execution of all day-to-day trial activities both locally and at participating sites, including participant screening and identification, informed consent, study intervention delivery, data collection, long-term follow-up, etc. This oversight includes the management and coordination of the local AIMS Clinical Research Assistants responsible for supporting both trials.
- Under the oversight of the Clinical Research Associate, oversee study-specific finances, including multi-center budget management, invoicing, supply orders, etc.
- In collaboration with the AIMS Research Ethics and Regulatory Coordinator, establish a Monito