Research Regulatory Manager

🕒 il y a 16 jours

🐎 Kentucky – Distant

info

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🚔 Conformité

🦅 Parrain de Visa H1B

info

🗣️🇺🇸🇬🇧 Anglais requis

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Logo of UofL Health

UofL Health

10 000+ employés

UofL Health est un système de santé universitaire régional intégré à but non lucratif 501(c)(3) comprenant neuf hôpitaux, quatre centres médicaux, le Brown Cancer Center, l'Eye Institute, plus de 250 cabinets de médecins et plus de 1 200 prestataires à Louisville et dans les comtés environnants, y compris le sud de l'Indiana. Un accès supplémentaire à UofL Health est offert grâce à un partenariat avec le Carroll County Memorial Hospital.

Description

• The Research Regulatory Manager position is responsible for developing the training and education for researchers • to meet the regulatory requirements to conduct clinical research studies in UL Health. • Build and maintain relationships with physicians, nurses, IT, Marketing, Supply Chain, and leadership. • Assist with development of goals, policies, and procedures • monitoring compliance with policies, procedures, and governing regulations • including the informed consent process and HIPAA authorizations. • Work closely with researchers and the corporate compliance team to identify and mitigate risks • Oversight of IRB submissions, study review process and research personnel vetting.

🎯 Exigences

• Bachelor’s degree (required) • Experience in clinical research • human subjects’ protection regulations • including HIPAA authorizations • IRB process (required) • 5 years of experience in research administration (preferred) • Professional certification such as CCRP, CHRC, ACRP-CP (preferred)

🏖️ Avantages

• none

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