Research Protocol Analyst

Emploi pas sur LinkedIn

🕒 il y a 3 jours

🇺🇸 États-Unis – Télétravail

💵 $37 - $57 / heure

⏰ Temps Plein

🟢 Junior

🟡 Intermédiaire

🧐 Analyste

🦅 Parrain de Visa H1B

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Foundation

Site WebLinkedInTous les Emplois

11 - 50 employés

₿ Crypto

🏪 Place de marché

🛍️ eCommerce

💰 €200 000 Seed Round en 2021-02

Crypto • Marketplace • eCommerce

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Description

• Manage the full lifecycle of research protocol review—pre‑reviewing submissions, coordinating expert committee evaluations, preparing regulatory documentation, and ensuring timely, compliant investigator responses to achieve Protocol Review and Monitoring Committees (PRMCs), and Institutional Review Board (IRB) approval. • Prepare complete meeting materials, provide regulatory guidance for complex submissions, and be fully knowledgeable about the ethical and regulatory requirements for conducting human subjects research to support and address committee questions during protocol reviews. • Experience interpreting and applying federal regulations when reviewing research protocols (exempt, expedited, and full board). • Strong attention to detail while managing complex and high volume of protocol review submissions. • Support external IRB oversight by performing reviews of the informed consent language for locally required boilerplate, assisting with annual worksheets and supplemental materials, and providing needed information when external institutions request to cede review. • Assist with preparation for internal and external audits and maintain audit ‑ ready protocols with complete, current, and compliant documentation. • Contribute to quality‑improvement efforts by identifying process efficiencies, staying current with regulations, updating policies, procedures, workflows, and electronic forms, enhancing reporting tools, and participating in educational sessions.

🎯 Exigences

• Bachelor’s degree (3 additional years of experience plus the minimum experience requirement may substitute for minimum education). • At least 2 years of experience in an IRB or Human Research Protection Program (HRPP) office, including review and processing of research submissions such as new studies, amendments, and continuing reviews in an academic medical center, research institution, or NCI-designated cancer center setting. • Availability to work weekdays from 8:00 a.m. to 5:00 p.m. Pacific Time. • Experience processing submissions in an electronic committee management system (e.g. iMedris/ IRIS, Cayuse, OnCore, eIRB). • Certified IRB Professional (CIP), Certified IRB Management (CIM), or other equivalent research certification.

🏖️ Avantages

• Comprehensive Benefits