Clin Research Assoc I/CPT PRDM/Cheng Lab | Cedars-Sinai Medical Center

Job Description JOB SUMMARY : ?? The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and / or implement the study.

This role evaluates and abstracts research data and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB.

Provides limited contact with research participants as needed for study and assists with study budget and research participant billing.

This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES : - Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse or Principal Investigator to coordinate / implement study.

• Evaluates and abstracts clinical research data from source documents. - Ensures compliance with protocol and overall clinical research objectives.
• Completes Case Report Forms (CRFs). - Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Provides supervised contact with research participants or contact for long term follow-up research participants only. - Assists with regulatory submissions to the Institutional Review Board (IRB) and 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.
• Assists with clinical trial budgets - Assists with patient research billing. - Schedules patients for research visits and research procedures.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits. - 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.
• Participates in required training and education programs including CSMC phlebotomy-specific clinical oversight which encompasses initial training, monthly assessments, six-month assessments, and annual assessments.
• Performs phlebotomy services according to CSMC policies and procedures. - Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results;
• takes appropriate action when corrections are indicated - Identifies patients and patient samples by strict adherence to established procedures;

labels samples accurately and completely. - Reports test results to appropriate individuals and exercises professional discretion with patient information.

Qualifications Educational Requirements : Bachelor of Arts OR Bachelor of Science degree?? OR Equivalent combination of education & experience.

Licenses : ??California Certified Phlebotomy Technician I or Certified Phlebotomy Technician II certification Experience : California Certified Phlebotomy Technician I or Certified Phlebotomy Technician II certification Physical Demands : - Able to perform moderate lifting.

• Able to sit, stand and walk for prolonged periods of time.?? - Able to read papers and online documents.?? - Able to operate standard office equipment.
• Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions. 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 : HRC0834755B Working Title : Clin Research Assoc I / CPT PRDM / Cheng Lab Department : Heart Institute Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Research Studies / Clin Trial Overtime Status : NONEXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $19.50 - $29.87