Enterprise Study Design Specialist

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.

Company Values:

At CRIO, we are dedicated to shaping the future of clinical research by ensuring that every study is designed and conducted with precision and innovation. Our commitment to excellence and continuous improvement drives us to provide the highest quality tools and education to our clients, enhancing the overall efficiency and success of clinical trials.

Job Summary:

The Study Design Specialist will play a critical role in ensuring the success of clinical trials by developing, implementing, and refining eSource study builds. This position requires a highly organized and detail-oriented individual who can collaborate effectively with clients, understand complex protocols, and ensure that all study designs meet regulatory and client-specific requirements.

Key Responsibilities:

  • Initiate Study Build Process:
    • Collect and review essential documents from clients, including study protocols, eCRF completion guidelines, data management documents, and EDC eCRFs.
    • Compile questions and clarify any uncertainties with the client.
    • Schedule and lead kick-off meetings to discuss study requirements and unique aspects.
  • Study Build and Design:
    • Create study shells in the appropriate CRIO environment based on geographical location.
    • Configure study visit schedules, including the number of visits, visit names, visit windows, and anchor visits as per the protocol.
    • Develop a Study Traceability Matrix documenting the study Schedule of Activities (SOA) versus eSource Procedures.
    • Add required procedures to the study build, including standard CRIO procedures and protocol-specific procedures.
  • Quality Control and Review:
    • Conduct thorough quality control reviews to ensure the study build's accuracy, completeness, and compliance with the protocol.
    • Address any necessary revisions identified during the review process.
  • User Acceptance Testing (UAT):
    • Collaborate with key sites and sponsors to conduct UAT workshops, ensuring all perspectives are considered for a faster resolution.
    • Log all edit requests in a shared document, maintaining transparency across stakeholders.
    • Implement feedback and make applicable changes within specified timelines.
  • Finalization and Go-Live:
    • Notify clients when the study build is ready for UAT and provide a feedback deadline.
    • Repeat the UAT process as necessary until the build is approved for go-live.
  • Ongoing Collaboration:
    • Work closely with cross-functional teams to ensure comprehensive and effective study designs.
    • Provide targeted education to clients to facilitate proficient system usage.
    • Develop tools to coach clinical research sites and sponsors through each visit, ensuring high-quality data and enhancing trial efficiency.

Qualifications:

  • Educational Background: Bachelor’s degree in a relevant field (e.g., Clinical Research, Life Sciences, Health Administration).
  • Experience: Minimum of 3 years in clinical trial design, implementation, or a related field.
  • Technical Skills: Proficiency in clinical trial software and tools (e.g., EDC, eSource, Budgeting systems). Experience with data visualization tools (e.g., Tableau, Looker) is a plus.
  • Soft Skills: Excellent communication, organizational, and project management skills. Ability to work collaboratively in a team environment.
  • Knowledge: In-depth understanding of clinical trial processes, regulatory requirements, and best practices.

Preferred Skills:

  • Experience in both site and sponsor environments.
  • Familiarity with CRIO system and its applications in clinical research.
  • Ability to translate complex data and requirements into actionable plans and designs.
  • Demonstrated ability to develop training materials and conduct educational sessions.

Working Conditions:

  • Location: Remote or office-based, depending on company needs and candidate preferences.
  • Hours: Full-time position with standard working hours. Flexibility may be required based on project timelines and client needs.

Salary Range - $75,000 --- $85,000


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.


CX

Remote (United States)

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