Lead Clinical Research Associate

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🔥 18 minutes ago

🌵 Arizona, California, +15 more states – Remote

🌵 Arizona – Remote 🏄 California – Remote 🐊 Florida – Remote 🌺 Hawaii – Remote 🌽 Illinois – Remote 🦬 Montana – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🎸 Tennessee – Remote 🤠 Texas – Remote ⚔️ Virginia – Remote ☕ Washington – Remote

💵 $102k - $164.8k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Duke Careers

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1924

💼 Consulting

🏥 Healthcare

📚 Education

Consulting • Healthcare • Education

Duke Careers is a platform connected to Duke University's rich legacy, established in 1924. It aims to celebrate the centennial of Duke University while providing resources, stories, and interviews that reflect the university's history, current achievements, and future aspirations. A key focus of Duke Careers is to engage with alumni and the community, showcasing the transformative impact of education and leadership within the university.

📋 Description

• Provide leadership, guidance, and oversight to the site management and monitoring team in collaboration with the Project Leader • Manage development, coordination, and implementation of site management and monitoring responsibilities for assigned projects • Supervise daily site management and monitoring team activities in accordance with contracts, guidelines, SOPs, regulations, ICH guidelines, and project scope • Coordinate and lead pre-study, initiation, periodic, and close-out site monitoring assignments and visits • Define site selection and activation guidelines and approve sites with project leaders and sponsors • Develop, maintain, and oversee study-specific processes, documents, templates, monitoring tools, and CTMS setup • Identify and act upon risk indicators to support risk-based monitoring strategies • Assign, coordinate, oversee, and assess team productivity, timelines, metrics, and deliverables • Provide guidance on site and project issues, resource needs, compliance, data integrity, and quality documentation • Review and approve team deliverables, reports, trip reports, site status reports, regulatory reports, payment reports, and expense reports • Participate in protocol, monitoring plan, scope of work, operations manual, CRF, query, and data-tool development • Facilitate communication among investigators, project leaders, internal and external partners, sponsors, and study sites • Organize and participate in study teleconferences, meetings, monitoring visits, audits, and inspections • Perform site selection, feasibility, initiation, training, regulatory-document, CRA, and corrective-action activities as needed • Mentor CRAs and coordinate trial-specific training, feedback, performance documentation, and retraining • Provide regulatory and compliance expertise, including source document verification, human subject protection, data integrity, drug accountability, and query resolution • Report study progress, site status, trial needs, findings, and action plans to internal and external stakeholders • Contribute subject matter expertise to department initiatives, cross-functional projects, and process improvements

🎯 Requirements

• Graduation from an accredited clinical-training degree program as a Registered Nurse, Physician's Assistant, or Pharmacist plus four years of healthcare experience; or an equivalent pathway • Allied health degree or associate’s degree in a Clinical Trials Research-related curriculum plus at least six years of healthcare experience • Master’s degree in Public Health, Health Administration, or a related area plus three years of directly related clinical trials research experience • Bachelor’s degree plus at least four years of directly related clinical trials research experience • Bachelor’s degree plus at least five years of closely related research experience • State of North Carolina license may be required • Ability to travel for on-site monitoring and study-related activities • Knowledge of contractual agreements, department guidelines, SOPs, applicable international, federal, and state regulations, ICH guidelines, and project scope of work • Expertise in site management, clinical trial monitoring, regulatory compliance, risk-based monitoring, CTMS, data integrity, and quality documentation • Ability to provide CRA guidance, mentorship, training, performance feedback, and oversight • Ability to assess protocol and regulatory compliance, source documents, human subject protection, CRF completion, data procedures, query resolution, and drug accountability

🏖️ Benefits

• Comprehensive and competitive medical care programs • Comprehensive and competitive dental care programs • Generous retirement benefits • Family-friendly and cultural programs