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Clinical Trials Nursing Specialist
4 months ago
Position Overview
The Clinical Research Nurse collaborates with a multidisciplinary team, including Research Coordinators and Assistants, to facilitate clinical trials focusing on Multiple Sclerosis (MS) and Neuromyelitis Optica (NMO) research. This role operates under the guidance of the MS Research Manager and is accountable to the Director of the MS Clinical Trials Group.
Key Responsibilities
- Reviewing research protocols and study designs with Investigators.
- Screening and enrolling participants in accordance with established study protocols.
- Collecting and documenting participant data accurately, including case report forms and other essential study documentation.
- Supporting departmental personnel to ensure compliance with study requirements.
- May involve the collection of biological samples and interpretation of test results as needed.
Organizational Structure
This position operates independently while adhering to ethical research practices. The Clinical Research Nurse reports to the Research Manager and the MS Clinical Trials Director, maintaining accountability to the Principal Investigators and the guidelines of the MS Clinical Trials group.
Work Duties
- Implementing study protocols and educating staff on compliance.
- Drafting and reviewing Informed Consent Forms for participants.
- Coordinating participant recruitment and screening processes.
- Providing information sessions for potential study participants.
- Maintaining accurate documentation and data collection tools.
- Ensuring adherence to Good Clinical Practice (GCP) guidelines.
- Monitoring participant progress and reporting any adverse events.
- Collaborating with various stakeholders, including sponsors and regulatory bodies.
Qualifications
Education and Experience
- Current registration with the relevant nursing regulatory body.
- A minimum of one year of clinical experience, preferably in Neurology or chronic disease management.
Skills and Competencies
Strong communication skills, both written and verbal, along with effective decision-making and analytical abilities. Proven capability to maintain accuracy and attention to detail while working under pressure. Ability to work autonomously and collaboratively within a team environment.
Work Environment
This position is situated within a clinical research setting, requiring attendance at meetings and potential travel for conferences. The role demands a commitment to maintaining high standards of participant safety and ethical research practices.
