Clinical Research Associate
1 day ago
The Clinical Research Coordinator / Project Manager plays a pivotal role in overseeing clinical trials and research studies to ensure compliance with regulatory standards and protocols. This position requires a strong understanding of clinical research methodologies, patient monitoring, and adherence to FDA regulations.
Key Responsibilities:
- Develop and write publications/articles, modify/ add new graphs, numbers, charts and verbiage with new updates.
- Work alongside cardiologists, neurologists, and orthopedic surgeons on publications.
- Develop and implement clinical research protocols in alignment with regulatory requirements.
- Ensure compliance with HIPAA regulations and maintain confidentiality of patient information.
- Monitor patient vital signs and collect relevant data during clinical trials.
- Utilize statistical software for data analysis and interpretation of research results.
- Collaborate with cross-functional teams to streamline clinical development processes.
- Train and supervise staff on clinical procedures, including phlebotomy techniques when necessary.
- Maintain thorough documentation of all research activities, ensuring accuracy and completeness.
- Stay informed about advancements in medical terminology and clinical research practices.
- Conduct regular audits to ensure adherence to study protocols and FDA regulations.
Requirements:
- Bachelor's degree in a relevant field (i.e. nursing, life science, public health)
- 5+ years of relevant experience or combination of education, training, and relevant experience.
- Clinical research writing is required.
- Advanced degree preferred.
- Strong knowledge of clinical research methodologies and practices.
- Proficiency in using statistical software for data analysis.
- Familiarity with medical terminology relevant to clinical trials.
- Experience in patient monitoring techniques and vital signs assessment.
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