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Clinical Research Associate II
2 months ago
Cedars-Sinai is seeking a highly motivated Clinical Research Associate II to join our dynamic team in the Department of Neurology.
The ideal candidate will have a strong background in clinical research and a passion for working in a fast-paced environment that offers the highest level of care to patients.
This role will involve coordinating and implementing clinical trials, evaluating and abstracting research data, and ensuring compliance with protocol and research objectives.
The Clinical Research Associate II will work closely with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to achieve these goals.
Key Responsibilities:
- Provides supervised contact with research participants or contact for long-term follow-up research participants only.
- Enters data into Electronic Data Systems (EDCs) that are provided by the sponsors.
- Works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
- Schedules research participants for research visits and research procedures.
- Responsible for sample preparation and shipping and maintenance of study supplies and kits.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- May participate in the development of Investigator-initiated trials for Investigational New Drug applications and/or Device applications.
- Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
- Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives.
Department-Specific Duties and Responsibilities:
- Transportation of research medications.
- Performs study-related assessments and questionnaires.
- Assists with prescreening of research participants for various clinical trials.
- Attends research meetings and monthly conference calls with sponsors for study updates.
- Maintains organized paper and electronic research files.
- Performs all data collection and data entry tasks for department clinical trials.
- Assists with preparing manuscripts, letters, and other research documents as needed.
- Responds to sponsor inquiries regarding protocol start-up activities and recruitment.
- Performs literature reviews.
Qualifications:
- High School Diploma/GED is required.
- 1 year of clinical research-related experience is required.
- Bilingual in Spanish.
About Us:
Cedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine, and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching, and community service.
Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
