Job Description
Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements! About the Team The MAST program at Cedars-Sinai Medical Center is dedicated to the development of novel drugs and devices to diagnose and treat patients. This innovative program is working to develop new diagnostics and therapeutics to treat patients with illnesses related to imbalances or alterations in the Microbiome. To learn more, please visit: .
About the Role The Clinical Research Coordinator II works independently providing study coordination including screening of patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The incumbent is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. The CRC II team member is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent presents information at research staff meetings.
Primary Duties and Responsibilities: - Schedules patients for research visits and procedures.
- In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) the following: changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
- Maintains accurate source documents related to all research procedures.
- Schedules and participates in monitoring and auditing activities.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
- Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- May coordinate training and education of other personnel.
- May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
- May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
- May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
- May identify new research opportunities and present to investigators
- Participates in required training and education programs.
Qualifications Education: - High School Diploma/GED is required.
- Bachelor's degree in a Science, Sociology, or related field is preferred.
Licenses/Certifications:
- ACRP/SOCRA certification is preferred.
Experience:
- Two years of clinical research experience, required.
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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. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. 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.
About the Team Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Job Tags
Full time, Local area,