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Research Coordinator
2 months ago
We are seeking a highly skilled and detail-oriented individual to join our team at Rehabilitation and Neurological Service, LLC as an Assistant Research Coordinator. This role will play a crucial part in the day-to-day running of human clinical trials, supporting the research team in various aspects of trial management.
Key Responsibilities:- Regulatory Compliance: Ensure adherence to standard regulatory submissions, including 1572 and IRB, to maintain the integrity of our clinical trials.
- Protocol Execution: Review and execute trial activities as outlined in the study protocol, ensuring accuracy and attention to detail.
- Training and Development: Direct and participate in protocol training for research staff, promoting a culture of knowledge sharing and expertise.
- Subject Informed Consent: Obtain informed consent from potential subjects, upholding the highest standards of patient care and respect.
- Documentation and Organization: Write SOPs and update source documents as needed, maintaining a well-organized and efficient system for trial management.
- Subject Binders: Organize subject binders, ensuring accurate and timely documentation of trial data.
- Audit Preparation: Have a working knowledge of sponsor/FDA audits, preparing the research team for any potential audits or inspections.
- Certifications and Experience: Possess GCP certification and previous clinical trial experience, with a strong understanding of computer skills, including Excel, Adobe, and Word.
- Device Familiarity: Familiar with device skills, including study devices, patient devices, iPhones, and other relevant equipment.
- Liaison and Communication: Act as the liaison between regulatory authorities and the research team, ensuring clear and effective communication.
- Additional Responsibilities: Perform other duties as needed, contributing to the overall success of our clinical trials.
- Integrity and Honesty: Demonstrate high integrity and honesty in all aspects of the role.
- Organization and Attention to Detail: Possess high organizational skills, with a keen eye for detail and a meticulous approach to work.
- Continuous Learning: Embody a growth mindset, with a commitment to ongoing learning and professional development.
- Paperwork Management: Be able to handle increased amounts of paperwork, maintaining a high level of productivity and efficiency.
- Compassion and Empathy: Display a compassionate and caring attitude, with a strong ability to work with patients and colleagues.
- Independence and Motivation: Demonstrate the ability to work independently, with a strong self-motivation and drive to achieve results.