Senior Coordinator, Meeting Coordination

🔥 il y a 20 heures

🇺🇸 États-Unis – Télétravail

💵 $66 767 - $116 089 / an

⏰ Temps Plein

🟠 Senior

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Advarra

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 1983

🏥 Santé

💼 Conseil

☁️ SaaS

Healthcare • Consulting • SaaS

Advarra est un fournisseur de technologie d'essais cliniques et de surveillance réglementaire intégrée, combinant l'examen indépendant de l'IRB et des services de conformité avec des plateformes SaaS d'entreprise (y compris Braid, OnCore, Clinical Conductor, eReg et eSource). L'entreprise offre une intelligence opérationnelle, un design de protocole et une automatisation alimentés par l'IA, une collaboration sur site, des outils de démarrage et d'inscription aux études, ainsi que des services de soutien stratégique aux promoteurs, CROs, sites de recherche et institutions pour améliorer l'efficacité, la conformité et la sécurité des patients tout au long du cycle de vie des essais cliniques.

Description

• Manage the IRB meeting workflow by reviewing incoming submissions and assigning reviews to Board members • Coordinate IRB meeting space/platform • Prepare informed consent forms (ICFs) before and after meetings in adherence to applicable federal regulations • Facilitate communication between Client Services, Board reviewers, and clients • 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 requiring 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 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 • Manage IRB meetings weekly on average and additional Board meetings as requested • Mentor new team members upon request

🎯 Exigences

• 2+ years of IRB experience • Bachelor’s degree, or a combination of education and experience • Certified IRB Professional (CIP) or attainment of CIP within one year of eligibility • Advanced knowledge of federal laws and guidelines pertaining to Human Subjects Research Protection • Proficiency with MS Word and Outlook • Completion of standard Human Subjects Research Training, e.g., CITI, as required by management • Fulfillment of organizational training requirements • Knowledge of U.S. and/or Canadian Regulations and Guidelines in Human Subject Protections and research areas • 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 • Reasonable accommodation for applicants with disabilities • Inclusive and collaborative workplace environment • Conferences, webinars, and workshops as agreed upon with management