Job Description

Job Title: Clinical Affairs Associate

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 \xe2\x80\x93 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 with the design and execution of clinical studies (and animal studies), including protocol development, investigator selection, training, and clinical operations to support the development and regulation of medical devices at FluidAI. The position will have overall accountability for timely conduct and preparation of clinical trials in Canada, US, Europe, Japan, and the Middle East. In addition, they will be responsible for data management/monitoring, interpretation, and reporting. 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\xe2\x80\x99s animal/clinical trials. We believe that diversity brings forward the best ideas. We are an equal opportunity employer and have a diverse team representation across language, ethnicity, gender, and nationality.

This position reports to the Director of Clinical Research. This is a hybrid position. You may be required to come into our offices located in Kitchener, ON.

Duties and Responsibilities

• Develop and maintain a comprehensive understanding of relevant regulations, guidelines, and industry best practices related to clinical research and medical device studies.
• Participate in the development and review of study protocols, informed consent forms, case report forms (CRFs), and other study-related documents and reports in compliance with the standards set forth by federal and provincial regulations, the ISO 14155, or regulatory bodies.
• Collaborate with cross-functional teams, including medical professionals, regulatory affairs, quality assurance, data management, and biostatistics, to ensure study objectives and timelines are met.
• Initiation.
• Identify potential sites for participation in clinical trials.
• Seek and interact with study investigators and research personnel from investigational sites.
• Assist in the preparation and submission of regulatory documents, such as Investigational Device Exemption (IDE) applications, Ethics Committee/Institutional Review Board (EC/IRB) submissions, and other regulatory filings.
• Coordinate and conduct site recruitment, site initiation visits, monitoring visits, and close-out visits for various study sites to ensure compliance with study protocols, good clinical practice (GCP) guidelines, and applicable regulations.
• 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
• Provide guidance and training to study site personnel on study procedures, documentation requirements, and regulatory compliance.
• Perform ongoing monitoring of study sites, including source data verification, query resolution, and assessment of protocol adherence and data integrity.
• Generate reports using the data collected through the Electronic Data Capture (EDC) system in a timely manner and in accordance with study-specific guidelines.
• Collaborate with clinical investigators and site staff to address any issues or concerns related to study conduct, data collection, and participant safety.
• Ensure accurate and timely reporting of adverse events (AEs), serious adverse events (SAEs), and other safety-related information to regulatory authorities, ethics committees, and study sponsors.
• Travel as necessary in accordance with study needs.
• Support the preparation of study-related reports, including clinical study reports (CSRs), interim analysis reports, and final study reports.
• Contribute to the development and implementation of standard operating procedures (SOPs) and quality control measures to ensure compliance and process improvements.
• Stay abreast of new developments and changes in regulations, guidelines, and industry trends related to clinical research and medical device studies.

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\xe2\x80\x99s 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 working in the medical device or pharmaceutical industry, preferably in clinical affairs, clinical research, or regulatory affairs.
• 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
• Excellent organizational and project management skills with the ability to prioritize tasks and meet deadlines
• Strong attention to detail and analytical skills for data review and interpretation
• Effective communication and interpersonal skills to collaborate with cross-functional teams and external stakeholders
• 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

FluidAI Medical