Study Design Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop thorough study builds from inception to completion within the CRIO platform

• Create eSource from protocols and electronic Case Report Forms (eCRFs)

• Perform post-build quality control assessments

• Set up budgets using the CRIO finance module

• Leverage protocols, eCRF guidelines, pharmacy manuals, lab manuals, and additional source documents to create detailed builds for clients

• Analyze Clinical Trial Agreements and budgets for integration into the CRIO finance module

• Plan visit schedules and procedures for CTMS-only studies

• Fulfill client-requested modifications and customizations

• Conduct quality control evaluations of client-developed eSource and budget templates

• Oversee complex trials to ensure accurate data capture

• Adapt standard templates to meet protocol specifications

• Ensure timely completion of assignments

• Mentor and provide training for both current and new CRIO staff

⛳️ Requirements

• Proven experience with eSource, budgeting, and quality control design in CRIO or other eSource/CTMS platforms

• Bachelor’s degree in a medical or scientific discipline (preferred)

• Minimum of 1 year of experience in the healthcare sector

• Ability to interpret clinical trial protocols, source documents, and clinical trial agreements effectively

• Familiarity with medical terminology and procedures

• Experience in monitoring study financials

• Excellent interpersonal skills

• Highly detail-oriented with strong time management abilities

• Well-organized, capable of setting priorities, and executing tasks efficiently

🏝️ Benefits

• Work remotely from anywhere (U.S. based)

• Unlimited paid time off (PTO)

• 401(k) company match

• Healthcare coverage

• Dental insurance

• Vision insurance (100% company paid)

• Life insurance coverage

• Professional Development Reimbursement

• Reimbursement for Work From Home expenses

• Occasional travel may be necessary depending on business requirements

• Some flexibility in working hours may be required to accommodate project timelines or time zone variations