FreshRemote.Work

Study Design Specialist - Part Time

United States - Remote

Who We Are: 

CRIO (Clinical Research IO) is a health tech company helping pharma, biotech, research sites, and academic research centers streamline regulatory workflows with one system and a single source of clinical data capture. Our modules allow sites to capture data electronically in real-time, providing data managers and monitors with enhanced transparency, and enabling remote monitoring by sponsors and CROs.

CRIO’s eSource and CTMS system is a leading, modern, enterprise platform built for clinical research sites. Since CRIO’s launch in 2016, CRIO has established the leading brand position in eSource and has won close to 50% of the emerging class of enterprise-grade site networks, many of whom are backed by institutional investors such as VC, PE and corporations. CRIO has achieved the attached metrics, all with little to no serious outbound sales or marketing.

In 2022, CRIO released its Reviewer product, a separate application that allows third parties to review, query, lock, medical code and extract source data collected in eSource. Reviewer is a flexible application that CRIO plans to commercialize with its own site networks, with third party vendors (e.g., overnight EDC entry services), and with sponsors and CRO’s as either a remote monitoring tool OR a full EDC solution. This innovative architecture is truly groundbreaking, and offers a new vision for how sponsors and CRO’s can drive quality and efficiency.

Role:


The Study Design Specialist is responsible for creating comprehensive study builds from start to finish in the CRIO platform. This includes developing eSource from protocols and eCRFs, and conducting post-build quality control reviews This individual will be considered an industry expert on the CRIO eSource module.

Responsibilities:

  • Utilize protocols, eCRF guidelines, pharmacy manuals, lab manuals, and other source documents to produce comprehensive builds for clients.
  • Complete client-requested edits and customizations.
  • Manage complex trials to ensure all data is captured appropriately.
  • Modify standard templates to comply with protocol requirements.
  • Complete assignments on time.
  • Mentor and train current and new CRIO employees.

Requirements

Responsibilities:

  • Utilize protocols, eCRF guidelines, pharmacy manuals, lab manuals, and other source documents to produce comprehensive builds for clients.
  • Complete client-requested edits and customizations.
  • Manage complex trials to ensure all data is captured appropriately.
  • Modify standard templates to comply with protocol requirements.
  • Complete assignments on time.
  • Mentor and train current and new CRIO employees.

Preferred Qualifications:

  • Experience with eSource and QC design in CRIO or other eSource/CTMS systems.
  • BS in medical or sciences field.
  • Experience as a Research Coordinator, Site Director, or Source Designer is a plus.

Other Qualifications:

  • At least 1 year of healthcare experience.
  • Ability to interpret clinical trial protocols, and source documents.
  • Knowledge of medical terminology and procedures.
  • Strong people skills.
  • Detail-oriented with solid time management skills.
  • Well-organized, capable of establishing priorities, and executing tasks efficiently.

Join us at CRIO and be part of a dynamic team dedicated to revolutionizing the clinical research industry. Apply today to embark on a rewarding career journey!

Equal Employment Opportunity

We’re proud to be an equal opportunity employer and welcome our employee’s differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Difference makes us better. Join us.

Benefits

This is a part time role:

Compensation Package - $20 an hour for all training and up to $450 for Study Design Build

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