Senior Clinical Research Associate

FluidAI Medical; Kitchener; Hybrid; CAD 60,000 - 100,000; Full time

Job summary

An innovative medical device organization is seeking a detail-oriented individual to join their clinical research team. This role involves supporting the design and management of clinical trials, ensuring compliance with regulatory standards, and creating essential study documents. You will collaborate with a high-performing team, contributing to groundbreaking technology aimed at improving post-operative care. With a flexible hybrid work model and a commitment to personal development, this position offers an exciting opportunity to make a significant impact in healthcare. Join a diverse team dedicated to saving lives and enhancing patient outcomes.

Benefits

Health and well-being benefits

Unlimited vacation

Paid parental leave

Regular offsite activities

Personal career development and training

Flexible hybrid work model

Qualifications

• Bachelor's degree in life science or related field required.
• Prior experience in conducting clinical trials is essential.

Responsibilities

• Support design and management of clinical and animal studies.
• Create study documents and ensure compliance with regulations.
• Conduct source document verification for clinical data.

Skills

Detail-oriented

Organizational skills

Clinical trial experience

Knowledge of ICH-GCP guidelines

Knowledge of ISO 14155

Communication skills

Ability to learn new software tools

Comprehension of medical terminology

Education

Bachelor’s degree in a life science or related field

Tools

Microsoft Office Suite

Electronic Data Capture (EDC) system

eTMF

CTMS systems

Job description

Company Description:

FluidAI Medical is a medical device organization creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart monitoring tool that can support earlier detection of deadly complications and enhance the delivery of care. We are an equal opportunity employer and have a diverse team representation across language, ethnicity, gender, and nationality.

Why join FluidAI?

• Mission to save lives and improve patient care with technology that is already deployed on patients in real-world settings.
• Work with a high-performing and cross-functional team that is empowered to grow, learn, and contribute across all levels of the organization.
• Personal career-focused development and training with access to workshops, coursework, and experienced mentors/consultants.
• Health and well-being benefits, including vision, drugs, dental, and life insurance.
• Regular offsite activities – past events include rafting, axe-throwing, sports leagues, and the usual BBQ.
• WFH/WFO flexible hybrid model.
• Unlimited vacation and paid parental leave.

Job Summary

The candidate would join the clinical research team to support the design, initiation, execution, management, data collection, and monitoring of FluidAI’s clinical and animal studies. They will participate in study design, seek appropriate investigators, and create clinical documents including protocols, case report forms (CRFs), memos, correspondence, reports, REB documentation, and other required documents, carry out source document verification, as well as facilitate the smooth operation of FluidAI’s animal/clinical trials. We believe that diversity brings forward the best ideas. This position will require you to come into our offices located in Kitchener, ON.

Duties and Responsibilities

• Seek and interact with study investigators, and research personnel from investigational sites.
• Identify potential sites for participation in clinical trials.
• Create study-related documents including protocols, CRF forms, reports in compliance with the standards set forth by federal and provincial regulations, the ISO 14155, or regulatory bodies.
• Prepare Independent Ethics Committee/Independent Regulatory Board (IEC/REB) submissions.
• Lead study design, site recruitment, initiation, and monitoring visits for various study sites.
• Conduct scheduled or ad-hoc check-ins with investigational sites, and research personnel as needed and administer ongoing protocol/study-related training to assigned sites.
• Conduct source document verification for clinical data from current and future clinical trials.
• Generate reports using the data collected through the Electronic Data Capture (EDC) system in a timely manner and in accordance with study-specific guidelines.
• Maintain study tracking in accordance with study demands using eTMF and CTMS systems.
• Travel as necessary in accordance with study needs.
• Advance clinical outreach by engaging new clinical partners.
• Assist the Clinical Operations team with Clinical Operations related tasks as needed.

Skills/Qualifications

You are detail-oriented and organized and can work independently in a fast-paced environment. You are not afraid to take the driver's seat, love to learn, and can quickly grasp new concepts as they arise during your work. If this sounds like you, we would love to meet you!

• Bachelor’s degree in a life science or related field of study.
• Prior experience conducting clinical trials.
• Thorough knowledge of the ICH-GCP guidelines.
• Thorough knowledge of ISO 14155 standard.
• Experience in grant and/or REB submissions.
• Experience in health research and database management.
• G2/G Driver with access to transportation for frequent travel to GTA and Hamilton.
• Proficiency in the use of Microsoft Office Suite.
• Strong written and verbal communication skills.
• Meticulous and detail-oriented.
• Ability to learn new software tools.
• Strong organizational skills and ability to multi-task.
• Comprehension of medical terminology is an asset.
• Experience with FDA and Health Canada guidelines in the context of clinical trials for medical devices is preferred.
• Experience with EU MDR standard is preferred.