Clinical Affairs Associate - Kitchener, Canada - FluidAI Medical

FluidAI Medical
FluidAI Medical
Verified Company
Kitchener, Canada

4 weeks ago

Sophia Lee

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Sophia Lee

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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 realworld settings.
  • Work with a highperforming and crossfunctional team that is empowered to grow, learn, and contribute across all levels of the organization.
  • Personal careerfocused development and training with access to workshops, coursework, and experienced mentors/consultants.
  • Health and wellbeing benefits, including vision, drugs, dental, and life insurance.
  • Regular offsite activities past events include rafting, axethrowing, sports leagues, and the usual BBQ.
  • WFH/WFO flexible hybrid model.
  • Unlimited vacation and paid parental leave.

Job Summary
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 studyrelated documents and reports in compliance with the standards set forth by federal and provincial regulations, the ISO 14155, or regulatory bodies.
  • Collaborate with crossfunctional 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.
  • Coordinate and conduct site recruitment, site initiation visits, monitoring visits, and closeout visits for various study sites to ensure compliance with study protocols, good clinical practice (GCP) guidelines, and applicable regulations.
  • Conduct scheduled or adhoc checkins with investigational sites, and research personnel as needed and administer ongoing protocol/studyrelated 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 studyspecific 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 safetyrelated information to regulatory authorities, ethics committees, and study sponsors.
  • Travel as necessary in accordance with study needs.
  • Support the preparation of studyrelated 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'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 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
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