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.

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!

Location & Travel:

This position is fully remote. You can work anywhere in the US with the expectation of being available based on EST time zone.

Benefits & Perks:

• Work from anywhere
• Unlimited PTO
• 401k company match
• Healthcare
• Dental
• Vision (Company Paid 100%)
• Life insurance
• Professional development
• 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.

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