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About the Role

Parachute is building the clinical operations and real-world evidence function to turn its national biologics platform into a recruitment and biospecimen engine. This role will design, launch, and advise on building a multi-site observational registry from the ground up, owning the registry from blank page to enrollment.

Responsibilities

• Lead end-to-end registry design and author the registry protocol, charter, informed consent / authorization language, regulatory packets, data dictionary, etc.
• Lead consent and privacy strategy, defending the choice to the IRB and internal legal/privacy.
• Select and engage the central IRB (Advarra or WCG); negotiate the Master Services Agreement and reliance framework.
• Build and execute the site-activation playbook, including feasibility, qualification, site participation agreements, BAAs/DUAs, regulatory packets, and training.
• Select and configure the EDC/registry platform (REDCap, Castor, Medidata RWS, or equivalent); spec CRFs, edit checks, and query workflows.
• Stand up the eTMF (Veeva Vault, Florence, or structured equivalent) to DIA TMF Reference Model standards.
• Achieve First Subject In within 6–9 months of start.

Requirements

• 8+ years in RWE and/or registry programs and/or phase 4 experience.
• Designed and built at least one registry from the ground up, including registry design, protocol authoring, and regulatory/start-up documentation.
• Led at least one multi-site observational registry or post-marketing study from protocol through enrollment or has deep experience in phase 4 trials.
• Comfortable operating in a data-collection paradigm (observational registries) as distinct from running an interventional experiment.
• Working command of ICH E6(R3) GCP, 45 CFR 46 (Common Rule), HIPAA Privacy/Security, and 21 CFR Part 11.
• Authored or successfully defended an IRB waiver of consent / waiver of HIPAA authorization.
• Direct working experience with Advarra and/or WCG as central IRB.
• Hands-on with at least one EDC/registry platform (REDCap, Castor, Medidata Rave RWS, OpenClinica, Veeva CDMS).
• Built and negotiated site participation agreements and BAAs/DUAs at scale (10+ sites).
• Been through at least one FDA BIMO inspection or rigorous sponsor audit.
• Significant and direct experience interacting with FDA CBER.
• Academic or research-institution registry experience (e.g., investigator-initiated or epidemiologic registries), in addition to or alongside industry experience.
• Blood, transfusion medicine, hematology, or apheresis exposure.
• Working knowledge of AABB standards, donor eligibility (21 CFR 630), and blood establishment regulations.
• Experience interacting with FDA, and CBER in particular.
• Start-up or small-company operating experience.
• Familiarity with state privacy law overlays (CCPA/CPRA, WA MHMD, TX HB 300).
• CCRP, CCRA, RAC, or CIP certification.
• Experience with payer/HEOR-driven registries.
• Exposure to eConsent platforms (DocuSign Life Sciences, Medidata Patient Cloud, Castor eConsent).

Skills

• RWE
• Registry programs
• Phase 4 experience
• Registry design
• Protocol authoring
• Regulatory documentation
• Consent strategy
• Privacy strategy
• IRB interaction
• Site activation
• EDC/registry platform configuration
• eTMF management
• ICH E6(R3) GCP
• 45 CFR 46 (Common Rule)
• HIPAA Privacy/Security
• 21 CFR Part 11
• Central IRB (Advarra/WCG)
• Site participation agreements
• BAAs/DUAs
• FDA BIMO inspection
• Sponsor audit
• FDA CBER interaction
• AABB standards
• Donor eligibility
• Blood establishment regulations
• Start-up operations
• State privacy laws (CCPA/CPRA, WA MHMD, TX HB 300)
• CCRP
• CCRA
• RAC
• CIP certification
• Payer/HEOR registries
• eConsent platforms

Location

• Austin, TX

Work Type

• Full Time
• In-house
• Sponsor-side

Experience Level

• 8+ years

About the Company

• Parachute operates a national, software-enabled biologics platform with 55 plasma and blood collection centers across 20 states, serving over 500k donors.
• The company's footprint serves as the foundation for a longitudinally-engaged donor population that can power the next generation of blood-based clinical research.
• Parachute is building the clinical operations and real-world evidence function that turns that network into a recruitment and biospecimen engine.