Lead Clinical Research Associate – Contract

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

⏳ Contrat

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 10%

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.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Configurer une alerte email pour les nouveaux emplois

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

ProTrials Research Inc.

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 1996

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

ProTrials Research Inc. est une organisation de recherche clinique (CRO) basée aux États-Unis, offrant une vaste gamme de services aux industries pharmaceutiques, biotechnologiques et des dispositifs médicaux. L'entreprise propose une gestion de site de qualité, une surveillance clinique, une gestion de projet, une gestion des données et des services de développement clinique de soutien. En se concentrant sur des domaines thérapeutiques tels que l'oncologie, l'ophtalmologie, le système nerveux central, les maladies infectieuses, la santé des femmes, et les dispositifs médicaux & diagnostics, ProTrials est dédiée à fournir des recherches cliniques de haute qualité. Leurs services incluent la gestion de projet, les opérations cliniques, l'assurance qualité, le soutien médical et réglementaire, et ils agissent également comme fournisseur de services fonctionnels, en mettant l'accent sur les essais virtuels et les capacités de surveillance à distance.

Description

• Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study • Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements • Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies • Create annotated visit report templates and other documents and strategies related to site management and monitoring • Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented • Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements • Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control • Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team • Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed

🎯 Exigences

• RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training • Previous CRA experience preferred • Proven excellence in professional skills including communication, organization, prioritization, presentation, discretion, and accuracy • Solutions-oriented approach to problem solving • Familiarity with medical and pharmaceutical industry, and related terminology and practices • Extensive knowledge of Food and Drug Administration regulations and their practical implementation • Willingness to travel and perform remote and on-site monitoring, if needed • Proficiency in Microsoft Word, Excel, and PowerPoint

🏖️ Avantages

• ProTrials is committed to providing a workplace free from discrimination and harassment. • All qualified candidates will receive equal consideration for employment without regard to race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.