About Equity Medical:
Equity Medical is a rapidly growing multi-site clinical research organization dedicated to expanding access to clinical trials in underserved communities across the United States. We partner with leading pharmaceutical and biotechnology companies to conduct high-quality research while leveraging technology to improve operational efficiency and patient care.
We are seeking an experienced eSource Implementation Specialist with hands-on experience building studies within the CRIO platform. This role is ideal for someone who enjoys translating clinical protocols into intuitive electronic source documents that support investigators, coordinators, and research teams.
What You'll Do:
As our eSource Implementation Specialist, you will design, build, validate, and maintain electronic source (eSource) documents within the CRIO platform to support successful clinical trial execution.
Responsibilities:
- Build, configure, and deploy eSource forms, visit schedules, workflows, and study structures within CRIO.
- Translate study protocols, Schedule of Events, assessments, and procedures into accurate and user-friendly electronic source templates.
- Ensure all eSource builds comply with Good Clinical Practice (GCP), FDA 21 CFR Part 11, ICH Guidelines, and Sponsor and internal quality standards.
- Collaborate with Clinical Operations, Investigators, Clinical Research Coordinators, Regulatory, and Data Management teams to gather study requirements.
- Participate in study startup activities, including CRIO study builds, User Acceptance Testing (UAT), Validation testing, Troubleshooting, and Go-live preparation.
- Validate all eSource builds to ensure workflow accuracy, logic functionality, protocol compliance, and optimal user experience.
- Identify and resolve build issues, discrepancies, and usability concerns prior to study activation.
- Maintain version control and documentation for all eSource builds.
- Update studies following protocol amendments and operational changes.
- Monitor system performance and recommend workflow improvements.
- Stay current on CRIO platform enhancements and implement new functionality when appropriate.
- Train site staff on CRIO eSource best practices.
- Provide ongoing support to clinical teams throughout study conduct.
What We're Looking For:
Required Qualifications:
- Bachelor's degree or equivalent clinical research experience.
- Experience building studies within the CRIO platform.
- Strong understanding of clinical trial workflows, study startup, eSource documentation, and clinical research operations.
- Knowledge of ICH-GCP, FDA 21 CFR Part 11, ALCOA+ principles, and clinical documentation standards.
- Ability to interpret study protocols and convert them into electronic workflows.
- Excellent attention to detail.
- Strong organizational and project management skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple study builds simultaneously while meeting deadlines.
Preferred Qualifications:
- Previous experience as a Clinical Research Coordinator (CRC), Regulatory Specialist, Clinical Trial Manager, or Clinical Research Associate (CRA).
- Experience supporting multi-site clinical research organizations.
- Experience with protocol amendments and study maintenance.
- Experience training research staff on eSource systems.
Work Arrangement:
- Remote.
- Independent Contractor (international contractor).
- Flexible schedule with required overlap during U.S. business hours for meetings and collaboration.
Why Join Equity Medical?
You'll help shape how clinical research teams capture high-quality source documentation across multiple sites while working alongside an innovative operations team committed to improving research efficiency through technology. Your work will directly impact study quality, compliance, and the success of clinical trials that bring new treatments to patients.
If you're passionate about clinical research technology and have hands-on CRIO experience, we'd love to hear from you.
