Associate, Clinical Operations

Job not on LinkedIn

🔥 0 minutes ago

🔔 Pennsylvania – Remote

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⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

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Logo of Red Nucleus

Red Nucleus

501 - 1000 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Red Nucleus is a company specializing in healthcare and life sciences services, offering a wide range of advisory and scientific services. With over three decades of experience, they provide solutions across the life sciences product life cycle, aiming to improve health outcomes. Their services include market access and commercialization, medical communications, and learning and development. Red Nucleus also offers products like DirectusPRO and iTakeControl. They focus on supporting strategic and operational challenges in healthcare through their expertise in areas like Quality, Clinical, Safety, Regulatory, and Medical Affairs. The company employs a team of over 700 members dedicated to advancing knowledge and improving lives.

📋 Description

• Support studies from startup through closeout • Manage sponsor, site, and vendor relationships • Participate in protocol design discussions and implementation planning • Develop IRB submission packages, training materials, caregiver/site manuals, and operational documentation • Lead or support Site Initiation Visits (SIVs), site training, and central rater training • Partner with Data Management, Product Management, and Technical Delivery teams • Support UAT and product launches

🎯 Requirements

• Undergraduate degree or equivalent professional experience • 1–10 years of experience • Experience operationalizing clinical study protocols, amendments, observational research studies, and registries • Professional experience within biotech, pharmaceutical, CRO, clinical site, or consulting environments • Knowledge of GCP, ICH, HIPAA, GDPR, FDA requirements, and clinical research regulations • Experience managing multiple research projects, vendors, sponsors, sites, and stakeholders simultaneously • Working knowledge of EDC, ePRO, EHR, and clinical research technologies • Strong written and verbal communication skills • Proficiency with Microsoft Office (Word, Excel, PowerPoint) • Digital health or mobile application experience preferred • Experience in rare diseases, gene therapy, or long-term follow-up studies preferred • Knowledge of clinical drug development pathways, including Phase I–III studies and registries preferred

🏖️ Benefits

• Equal opportunity employment • Inclusive workplace culture • Diversity, equity and inclusion valued • No discrimination based on race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status

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