Stryde Research is a site management organization based inTexas. W e run more than 20 clinical research sites across Texas and East Coast. Our studies cover dermatology, rheumatology, cardiology, and others.

We started Stryde to make clinical research more human and to bring trials to communities that usually get left out of them. That only works if our data holds up. Sponsors trust our sites because our files are clean, and patients trust us because we protect them. This role sits right at the center of both.

Role

We're hiring a GCP auditor to be an independent set of eyes across our sites. You'll audit study conduct against ICH GCP, FDA regulations, and our SOPs, then work with coordinators and investigators to fix what you find and keep it fixed.

This is a fully remote position. You'll work Monday through Friday, 9:00 a.m. to 5:00 p.m. Central Time, so your day lines up with our site teams and leadership in Texas.

- Plan and run remote internal audits of active studies. That means regulatory binders and eISF, informed consent, eligibility, source-to-EDC verification, IP accountability, AE and SAE reporting, delegation logs, and training records.
- Run routine audits on a set schedule, and for-cause audits when something goes wrong, such as a consent deviation or a sponsor finding.
- Write audit reports with findings graded by risk,



and follow each CAPA through to an effectiveness check.
- Get sites ready for sponsor audits and FDA BIMO inspections, including mock inspections and staff interview prep.
- Update SOPs when an audit shows a gap between what the SOP says and what sites actually do.
- Trend findings across sites and studies, and report them to leadership each month.
- Train coordinators and investigators on GCP and ALCOA+ documentation, using real examples from recent audits.
- Track regulatory changes, including the E6(R3) rollout, and turn them into practical guidance for sites.

Required

- Bachelor's degree in life sciences, nursing, or a related field, or equivalent experience.
- 3+ years in clinical research QA or GCP auditing, or 5+ years at the site level (CRC, CRA, or regulatory) with hands-on audit experience.
- Working knowledge of ICH E6(R3) and 21 CFR Parts 11, 50, 54, 56, and 312 (Part 812 for device studies).
- Comfort auditing remotely in eISF, eReg, and EDC systems.
- Transparent, direct writing. Your findings should tell a site exactly what to fix.
- Reliable availability 9:00 a.m. to 5:00 p.m. Central, Monday through Friday, with stable internet and a private workspace suitable for reviewing PHI.

📌 GCP Auditor (India)
🏢 Stryde Research
📍 India