Site Monitor

🕒 il y a 15 jours

🇺🇸 États-Unis – Télétravail

💵 $50 000 - $75 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

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Discovery Life Sciences

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 2018

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Discovery Life Sciences est un fournisseur mondial de biospécimens humains obtenus de manière éthique, de matériaux de départ pour les thérapies cellulaires et géniques, ainsi que de services de laboratoire spécialisés intégrés. L'entreprise dispose d'un vaste inventaire commercial de biospécimens et d'un réseau mondial de collecte clinique, et propose des services de génomique, protéomique, pathologie moléculaire, cytométrie en flux, ADMET et autres services multi-omiques et de biologie cellulaire pour soutenir la recherche préclinique, translationnelle et clinique dans le développement de biopharma, diagnostics et thérapies cellulaires et géniques.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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