Job Description

Clinical Research Nurse

Position Summary:

The Clinical Research Nurse is responsible for conducting clinical studies in compliance with FDA, CFR, and ICH regulations and guidelines. This role manages all aspects of clinical trials from study startup through closeout, ensuring the accuracy, integrity, and regulatory compliance of all study activities.

Key Responsibilities

Study Coordination and Execution

• Conduct clinical trials from feasibility through study closeout in compliance with FDA, CFR, and ICH regulations.
• Coordinate and facilitate communication between departments, investigators, and sponsors to ensure timely study startup and first patient enrollment.
• Maintain in-depth knowledge of study protocols to ensure all procedures are executed accurately and completely.

Training and Education

• Train site personnel and medical staff on study-specific protocols, regulatory requirements, and sponsor expectations.
• Educate study participants, families, and caregivers on protocol requirements and their relationship to the disease process.

Regulatory and Sponsor Communication

• Communicate with sponsors, IRBs, physicians, and regulatory bodies regarding study conduct, data review, and other essential activities.
• Prepare and maintain all required regulatory documentation, including IRB submissions, informed consent forms, amendments, adverse event reports, and advertisements.

Participant Recruitment and Management

• Develop and implement recruitment strategies to meet study enrollment goals.
• Screen and register study participants in accordance with inclusion and exclusion criteria.
• Be available for after-hours and weekend participant registration as needed.
• Schedule and conduct study visits, ensuring all required assessments and procedures are completed accurately.

Data and Documentation

• Complete Case Report Forms (CRFs) accurately, completely, and in a timely manner.
• Maintain accurate case histories and source documentation for each study subject.
• Record all observations, adverse events, and study-related activities in compliance with GCP and ICH guidelines.
• Maintain accurate records of receipt, administration, and return of investigational products and clinical supplies.

Compliance and Quality Assurance

• Ensure the safety and welfare of all study subjects.
• Obtain written informed consent from participants prior to study participation.
• Follow electronic source documentation guidelines, ensuring appropriate certification and secure maintenance of all study records.
• Maintain regulatory binders, source documents, and other essential study files for audit readiness.

Professional Development

• Maintain required certifications such as RN and BLS, and complete ongoing training in GCP, Human Subjects Protection, and other study-specific requirements.

Qualifications

• Registered Nurse (RN) or equivalent clinical background preferred.
• Strong knowledge of GCP, ICH, and FDA regulations.
• Excellent organizational and communication skills.
• Ability to manage multiple studies and prioritize tasks effectively.
• Willingness to work flexible hours, including after-hours and weekends, as needed.

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