Clinical Research Associate I- Smidt Heart Institute (Makkar Lab)

National Medical Association; Los Angeles (CA); On-site; Full time

Job summary

An established industry player is seeking a Clinical Research Associate I to join their dynamic team. In this engaging role, you will work closely with clinical research professionals to coordinate and implement studies, ensuring compliance with all necessary guidelines. Your responsibilities will include evaluating research data, assisting with regulatory submissions, and maintaining patient confidentiality. This position offers the chance to be part of a leading organization that is dedicated to transforming healthcare and improving patient outcomes. If you're passionate about research and eager to make a difference, this opportunity could be perfect for you.

Qualifications

• 1 year of clinical research experience preferred.
• High school diploma required; Bachelor's preferred.

Responsibilities

• Coordinate and implement clinical studies with research teams.
• Evaluate and abstract clinical research data from source documents.
• Ensure compliance with federal and local guidelines.

Skills

Clinical Research Coordination

Data Evaluation and Abstraction

Regulatory Submissions

Good Clinical Practice (GCP)

Patient Confidentiality

Education

High School Diploma

Bachelor's Degree

Tools

Electronic Data Systems (EDCs)

Case Report Forms (CRFs)

Job description

Key Job Responsibilities

The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assisting with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assists with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Primary Duties and Responsibilities

1. Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
2. Evaluates and abstracts clinical research data from source documents.
3. Ensures compliance with protocol and overall clinical research objectives.
4. Completes Case Report Forms (CRFs).
5. Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
6. Provides supervised patient contact or patient contact for long term follow-up patients only.
7. Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
8. Assists with clinical trial budgets.
9. Assists with patient research billing.
10. Schedules patients for research visits and research procedures.
11. Responsible for sample preparation and shipping and maintenance of study supplies and kits.
12. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
13. Maintains research practices using Good Clinical Practice (GCP) guidelines.
14. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
15. Participates in required training and education programs.

Qualifications

Educational Requirements:

• High school Diploma Required
• Bachelor's Degree Preferred

Licenses: N/A

Experience: 1 year clinical research experience preferred

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 Los Angeles that need our care the most.

Req ID: HRC1418635

Working Title: Clinical Research Associate I- Smidt Heart Institute (Makkar 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