Senior Coordinator, Meeting Coordination

🔥 il y a 20 heures

🇺🇸 États-Unis – Télétravail

💵 $66 767 - $116 089 / an

⏰ Temps Plein

🟠 Senior

👻 Score fantôme 0%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Advarra

Advarra

501 - 1000 employés

Fondée en 1983

💼 Conseil

📦 Logistique

📣 Marketing

Consulting • Logistics • Marketing

Advarra est un fournisseur de technologies et de services intégrés pour la recherche clinique, combinant des services de révision institutionnelle et de conformité avec des plateformes logicielles pour soutenir l'ensemble du cycle de vie des essais cliniques. L'entreprise propose des services de révision éthique (IRB, IBC, DMC, adjudication des critères de jugement), la promotion des sites et le recrutement de personnel de recherche, ainsi qu'une suite de produits cloud — y compris eRegulatory, eConsent, eSource/EDC, CTMS et des outils de conception d'étude — en plus d'un moteur d'intelligence opérationnelle alimenté par l'IA (Braid) pour rationaliser le démarrage, l'enrôlement et les opérations des essais. Advarra sert des commanditaires, CRO, sites de recherche et institutions avec un accent sur la protection des patients, la conformité réglementaire et l'accélération des résultats des essais.

Description

• Facilitate communication between Client Services, Board reviewers, and clients • Prepare meeting and post-meeting informed consent forms reflecting Board concerns and edits • Prepare proposed meeting determinations for Chair review • Host the web platform for IRB meetings • Provide pre- and during-meeting support to Chairs and Board Members for regulatory compliance • Manage complex issues arising during IRB meetings • Identify and address issues needing attention by the IRB and Chair • Challenge or clarify opinions and questions during IRB meetings • Collaborate with Client Services on reporting special issues to the IRB • Analyze and recommend improvements to IRB review methods • Conduct accurate pre-reviews of consent forms for regulatory compliance • Edit consent forms to align with regulatory standards and Advarra operational guidelines • Apply negotiated language to consent forms according to client agreements • Collaborate with stakeholders to incorporate necessary edits • Perform quality-control checks on consent forms • Stay updated on U.S. and/or Canadian regulations and guidelines in human-subject protections and research areas • Complete standard Human Subjects Research Training, such as CITI, according to management’s cycle • Fulfill organizational training requirements • Attend conferences, webinars, and workshops as agreed with management • Manage IRB meetings weekly on average, plus additional Board meetings as requested by management • Mentor new team members upon request

🎯 Exigences

• 2+ years of IRB experience in addition to a bachelor’s degree; or a combination of education and experience • Certified IRB Professional (CIP) or attainment of CIP within one (1) year of eligibility • Advanced knowledge of Federal laws and guidelines pertaining to Human Subjects Research Protection • Proficient with MS Word and Outlook • Ability to sit or stand for extended periods at a stationary workstation • Ability to regularly carry, raise, and lower objects of up to 10 Lbs. • Ability to learn and comprehend basic instructions • Focus and attention to tasks and responsibilities • Verbal communication, listening and understanding, responding, and speaking

🏖️ Avantages

• Variable bonus eligibility in addition to base salary • Health coverage • Paid holidays

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