Job description

A key role in conducting clinical trials to assess the safety and efficacy of RCE’s technology is that of a clinical trials coordinator. In this role, you will be involved in all phases of a clinical trial - From adhering the study protocol with the objectives and regulatory standards, to initiating the trials with the clinical research team, you will facilitate all necessary product training and data collection efforts that will be needed for the trial. While conducting the clinical trial, you should have a sound knowledge of the study protocol and support the clinical research team in conducting the study.

The ideal candidate is a person with medical background and excellent interpersonal skills, a versatile thinker who will proactively manage the operational aspects of medical research studies of the company through close collaboration with product engineering, regulatory affairs, and interaction with clinical partners. Typically working under the direction of RCE’s scientist or medical researcher, the clinical trial coordinator will use use clinical trials to test the effectiveness and safety of a new product.

Roles

  • Aligning clinical study research coordinator/PI with product use and study objectives
  • Onboarding clinical trials with partners
  • Overseeing the smooth running of clinical trials
  • Coordinate the study's data collection process and file the necessary reports regarding the study's progress
  • Managing research budget and funds allocation
  • Reviewing study protocols to ensure compliance with regulatory standards

Responsibilities

  • Initiating operational aspects of clinical partnership - NDA, CTA
  • Conducting site initiation visits, product training and reference collateral for clinical research team
  • Informing clinical research team about study objectives and timelines for completion of key efforts
  • Educating clinical study team regarding the study design, methods and data collection aspects of the research study.
  • Reviewing data for various aspects of the medical study to check for accuracy
  • Adhering to research regulatory standards
  • Adhering to ethical standards
  • Maintaining detailed records of studies as per FDA guidelines
  • Liaising with laboratories where sample transfer and analyse measurement is required
  • Ensuring that the necessary supplies and equipment for a study are in stock and in working order
  • Compile information as required to scientist, medical researcher, or medical writer working towards a manuscript regarding the study's findings

Requirements

  • Individuals with experience in research and an associate's degree in applied science
  • 2+ years in conducting healthcare research activities
  • Excellent organizational skills with attention to detail
  • Exceptional interpersonal skills
  • Outstanding written and verbal communication
  • Experience with Google and Microsoft suite of products