Site Monitor

🕒 Agosto 25

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $50.000 - $75.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

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Esta empresa já patrocinou vistos H1B no passado.

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Discovery Life Sciences

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2018

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Discovery Life Sciences é uma fornecedora global de biospecímenes humanos obtidos eticamente, materiais iniciais para terapia celular e gênica, e serviços laboratoriais especializados integrados. A empresa mantém um grande inventário comercial de biospecímenes e uma rede mundial de coleta clínica, oferecendo serviços de genômica, proteômica, patologia molecular, citometria de fluxo, ADMET e outros serviços multi-ômicos e de biologia celular para apoiar a pesquisa pré-clínica, translacional e clínica para biofarmácia, diagnósticos e desenvolvimento de terapia celular e gênica.

Descrição

• Monitor the clinical site network to support data quality and integrity and ensure adherence to procedures and protocols • Conduct and document regular remote or on-site monitoring visits • Resolve outstanding issues and compile detailed monitoring reports • Collaborate with Clinical Affairs Managers and site personnel on regulatory documentation, data integrity, and protocol adherence • Identify and resolve site-specific challenges, including retraining, corrective actions, and issue escalation • Manage timelines and documentation across multiple clinical trial sites • Manage, coordinate, and support clinical site monitoring activities • Schedule visits, obtain proper access, and complete monitoring plans with the Clinical Affairs Manager • Review data according to monitoring guidelines, ensure documentation is present, and compile findings • Monitor client projects as required by researchers and biopharmaceutical clients • Resolve protocol questions and ensure outstanding documents are completed properly • Collect, accurately file, and update regulatory and site-specific documentation • Partner with Quality and the site’s Clinical Affairs Manager on promptly reportable incidents • Review monitoring reports and protocol deviations to identify site- and study-level trends • Develop study materials and improve study documents to mitigate risk • Travel to clinical sites at least annually when remote monitoring is unavailable • Maintain collaborative relationships with Discovery personnel • Participate in departmental process-improvement activities • Stay abreast of industry-accepted procedures and educate team members on standards and policies • Collaborate to improve study-information tracking methods • Maintain accurate data in the Salesforce database and use communication tools • Protect the privacy of patients, co-workers, and other individuals’ personal information

🎯 Requisitos

• 5+ years of experience in clinical trial research with monitoring oversight preferred • 3–5 years of comparable or related medical experience • Experience in a clinical research organization or oncology/infectious disease/autoimmune therapeutic specialties • Familiarity with principles, concepts, standards of care, and clinical study design • Highly developed organizational and analytical skills • Ability to multitask, prioritize time-sensitive activities, and work independently and in a matrix environment • Excellent presentation, communication, and relationship-building skills • Ability to develop trust and maintain integrity with external clinical and scientific experts, institutions, peers, and others • Ability to analyze problems and develop and implement strategic solutions • Ability to work independently and with interdisciplinary teams • Strong proficiency with MS Suite • Ability to travel to clinical sites up to 50% of the time • Preferred home base near an international airport • Experience with Salesforce.com and MediaLab desirable but not required • Experience with electronic medical records (EMR) desirable but not required • Must be able to work Monday–Friday with a start time between 7am and 9am local time • Applicants must be authorized to work in the United States; visa sponsorship is unavailable

🏖️ Benefícios

• Medical, dental, vision, life, and disability benefits starting on the first day of employment • 401(k) match program starting on the first day of employment • Generous vacation and paid time off • Paid parental leave • Paid family leave • Professional development opportunities • Reimbursement for relevant certifications • Collaborative and inclusive work environment that values diversity • Team-building activities and social events • Employee Referral Program • Colleague Recognition Program