Job Description

Clinical Research Coordinator I CPT - Emergency Medicine - Full-Time, On-Site, Evenings at CEDARS-SINAI summary:

The Clinical Research Coordinator I independently manages clinical research studies, including screening patients for eligibility, coordinating study visits, and ensuring compliance with protocols and regulatory requirements. They handle data collection, documentation, reporting, and communication with sponsors and regulatory bodies while maintaining patient confidentiality under HIPAA. This role involves collaboration with medical staff, participation in audits, and adherence to Good Clinical Practice guidelines in an emergency medicine setting.

Job Description

Come join our team!

The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings.

What are the primary duties and responsibilities?

• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
• Schedules patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly 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 / IRB 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 IRB.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.

Qualifications

Education, Experience & Certification Requirements:

• High School Diploma/GED required. Bachelor's Degree in Science, Sociology, or related degree preferred
• One (1) year of clinical research related experience required
• Certification in Clinical Research (SOCRA or ACRP) preferred
• CA Phlebotomy Certification required upon hire
• Prior ED experience desirable.

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.
Req ID : 10330
Working Title : Clinical Research Coordinator I CPT - Emergency Medicine - Full-Time, On-Site, Evenings
Department : Research - ED
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Evening
Shift Duration : 8 hour
Base Pay : $23.39 - $39.76

Keywords:

clinical research, study coordination, patient screening, protocol compliance, data collection, informed consent, FDA regulations, Good Clinical Practice, HIPAA compliance, emergency medicine

Job Tags

Full time, Local area, Shift work, Afternoon shift,

Similar Jobs