Job Description

Clinical Research Nurse Manager

Our agency is seeking a skilled Clinical Research Nurse Manager to support one of our healthcare research partners. This role provides leadership to a centralized clinical research unit, ensuring that all studies are conducted with precision, regulatory integrity, and a high standard of patient care. Working closely with Principal Investigators and a Research Director, the Clinical Research Nurse Manager will oversee daily operations while also contributing hands-on support to clinical trials.

Key Responsibilities

Operational Leadership

• Manage the daily workflow of a Central Clinical Research Unit, offering oversight and direction for a team of up to 10 Clinical Research Coordinators.
• Collaborate with the Research Director on staffing strategies, resource allocation, performance evaluations, and workload balancing.
• Assess short- and long-term staffing demands and adjust schedules to maintain safe and efficient clinical research operations.

Training, Quality & Regulatory Compliance

• Ensure that credentialing, documentation, and study activities align with ICH-GCP standards, FDA regulations, HIPAA requirements, and internal policies.
• Lead a structured onboarding and ongoing training program for Clinical Research Nurses and Coordinators.
• Support regulatory personnel in maintaining accurate and compliant study documentation.

Study Execution & Patient-Focused Research

• Review potential study protocols, assess feasibility, and collaborate with PIs and sponsors during trial planning and activation.
• Oversee patient enrollment, retention, and follow-up across multiple therapeutic areas.
• Provide direct clinical care as needed, including administering investigational treatments, performing assessments, and educating participants on study procedures.

Team & Sponsor Collaboration

• Serve as a key liaison for internal teams, external sponsors, research partners, and study participants.
• Assist with study-startup documentation such as NDAs, DUAs, BAAs, contracts, budgets, and coverage analyses.
• Contribute to research technology improvements, operational dashboards, newsletters, and communications initiatives.

Quality Assurance & SOP Development

• Participate in the creation and refinement of SOPs and quality improvement processes.
• Support internal and external audits, identify process gaps, and assist with corrective and preventive actions.
• Develop and maintain strong relationships with industry sponsors and build a network of research contacts.

Additional Responsibilities

• Provide clinical oversight across therapeutic areas and mentor staff on complex clinical tasks.
• Ensure strict adherence to study protocols and regulatory requirements.
• Adapt to shifting priorities and perform other responsibilities as required.

Qualifications

Education

• Bachelor of Science in Nursing (BSN) required.

Experience

• Minimum 5 years of recent clinical nursing experience in a hospital, clinic, or comparable setting.
• Minimum 5 years of experience in clinical research as a Nurse, Coordinator, or Manager.
• At least 1 year of clinical trials experience preferred.

Skills & Competencies

• Strong RN clinical skills (vital signs, assessments, ECG/EKG, phlebotomy, injections, etc.).
• Solid understanding of ICH-GCP and clinical research regulatory frameworks.
• Highly detail-oriented with strong follow-through and problem-solving skills.
• Effective communicator with strong interpersonal, team leadership, and customer-service skills.
• Comfortable multitasking and working under time-sensitive conditions.
• Proficient in Google Workspace, Microsoft Office, EHR systems, and research databases.

Licensure & Certifications

• Active Registered Nurse (RN) license in New Jersey or a valid compact license accepted in NJ.
• Basic Life Support (BLS) certification through the American Heart Association.

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