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Study Design Specialist

Role overview

Qualifications

  • Experience with eSource, budget, and QC design in CRIO or other eSource/CTMS systems
  • BS in medical or sciences field
  • At least 1 year of healthcare experience
  • Strong people skills

Responsibilities

  • Utilize protocols, eCRF guidelines, pharmacy manuals, lab manuals, and other source documents to produce comprehensive builds for clients
  • Interpret Clinical Trial Agreements and budgets for configuration in the CRIO finance module
  • Design visit schedules and procedures for CTMS-only studies
  • Provide quality control reviews of client-built eSource and budget templates

Key facts

Other skills

  • Budgeting
  • Quality Control
  • Detail Oriented
  • Time Management
  • Organizational Skills
  • Social Skills

About the company

CRIO logo

CRIO

Digital Health & Health Tech

CRIO is a health tech company helping pharma, biotech, research sites, and academic research centers streamline regulatory workflows with one system that enables a single point of data capture. As the leader in eSource technology, CRIO enables remote monitoring and immediate data review with a powerfully integrated eSource/EDC solution. The system delivers a single point of data capture, eliminating the need to re-enter data into EDC. At CRIO, our mission is to design and deliver a modern, intuitive and integrated software platform that reimagines clinical trials for quality, speed, and patient-centricity. CRIO keeps your source data secure and protects data integrity with built-in compliance across 21 CFR 11, ICH-GCP, GDPR, HIPAA, and other global regulations. Now you can bring trials to patients where they're at and access that data anytime, anywhere. For sites, CRIO is an enterprise tool for clinical trial management. For sponsors and CROs, CRIO serves as a single data platform for centralized monitoring. Our software frees you from inefficient, error-prone binders to capture source data. CRIO’s autofill and data validation tools reduce protocol deviations and save time. With patient scheduling, recruiting, financial management, and so much more, CRIO is an all-in-one enterprise solution for sites, sponsors and CROs.

Company details

Company typeScaleup
IndustryDigital Health & Health Tech
Company size51 - 200

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Job description

CRIO is a leading provider of eSource solutions for clinical research. Our platform streamlines clinical data collection and management, ensuring protocol compliance and reducing errors. By eliminating paper binders and automating workflows, we help clinical trial sites and sponsors save time and money, improve data quality, and enhance patient safety. Our digital-first, site-centric approach supports virtual, hybrid, and traditional study structures, making clinical trials more efficient and effective.


Founded in 2015 by a clinical trial site owner seeking to improve his own business, today CRIO is the industry leader in site eSource with a fast-growing presence serving sponsors and CROs. CRIO is in use on 6000+ protocols at more than 2500 sites in 30 countries. In fact, the strength of our site community drives our growth which is why we place so much value on hands-on clinical research experience.



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, conducting post-build quality control reviews, and configuring budgets in our finance module. This individual will be considered an industry expert on the CRIO eSource and Finance modules.

Responsibilities:

  • Utilize protocols, eCRF guidelines, pharmacy manuals, lab manuals, and other source documents to produce comprehensive builds for clients.
  • Interpret Clinical Trial Agreements and budgets for configuration in the CRIO finance module.
  • Design visit schedules and procedures for CTMS-only studies.
  • Complete client-requested edits and customizations.
  • Provide quality control reviews of client-built eSource and budget templates.
  • 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, budget, 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, source documents, and clinical trial agreements.
  • Knowledge of medical terminology and procedures.
  • Experience tracking study financials.
  • 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!


Benefits & Perks

  • Work from anywhere (US based)
  • Unlimited PTO
  • 401k company match
  • Healthcare
  • Dental
  • Vision (Company Paid 100%)
  • Life insurance
  • Professional Development Reimbursement
  • Work From Home Expense Reimbursement


Equal Employment Opportunity

CRIO is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are made based on qualifications, merit, and business need without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other basis protected by federal, state, or local law.


Working Conditions

This is a full-time remote position. Occasional travel may be required based on business needs. Some flexibility in working hours may be needed to accommodate project schedules or time zone differences.


Disability Accommodation Statement

We are committed to providing reasonable accommodations to individuals with disabilities in the application and interview process. If you require accommodation to participate in the application process, please contact Human Resources to request assistance.


Salary Range: $60,000 --- $70,000


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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
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