Head of Clinical – Registry Programs

🔥 3 hours ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🔴 Lead

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Join Parachute

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

📦 Logistics

🏨 Hospitality

💰 $57.6M Funding Round - Parachute on 2023-12

Healthcare • Logistics • Hospitality

Join Parachute is a consumer-facing platform and network of plasma donation centers that makes it easy for people to schedule plasma donations, track earnings, and receive payment via a partner-issued prepaid Visa card. Through a mobile app, Parachute lets donors book one-hour donation slots, access bonuses for flexible scheduling, monitor their balances, and get paid for contributing plasma. The company emphasizes a hospitality-focused, tech-enabled member experience and a mission to increase access to life-saving plasma while providing financial incentives to donors.

📋 Description

• Lead end-to-end registry design and author the registry protocol, charter, informed consent / authorization language, regulatory packets, data dictionary, etc. in partnership with the medical director and steering committee. • Lead consent and privacy strategy: full consent vs. HIPAA waiver vs. limited data set + DUA. Defend the choice to the IRB and to 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: feasibility, qualification, site participation agreements, BAAs/DUAs, regulatory packets, 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. • Get to **First Subject In** within 6–9 months of start.

🎯 Requirements

• 8+ years in RWE and/or registry programs and/or phase 4 experience • Has designed and built at least one registry from the ground up — registry design, protocol authoring, and the regulatory/start-up documentation to set it up — whether in an industry/sponsor-side or academic/research setting. 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 — you understand the design, governance, and quality demands specific to systematically collecting longitudinal real-world data. • Working command of ICH E6(R3) GCP, 45 CFR 46 (Common Rule), HIPAA Privacy/Security, and 21 CFR Part 11. • Has 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). • Has built and negotiated site participation agreements and BAAs/DUAs at scale (10+ sites). • Has been through at least one FDA BIMO inspection or rigorous sponsor audit. • Has significant and direct experience interacting with FDA CBER • **Strongly Preferred ** • 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).**** • **Nice to Have** • CCRP, CCRA, RAC, or CIP certification. • Experience with payer/HEOR-driven registries. • Exposure to eConsent platforms (DocuSign Life Sciences, Medidata Patient Cloud, Castor eConsent).