Clinical Research Coordinator III - Cardiology Research - Makkar Lab

Cedars-Sinai; Los Angeles (CA); On-site; USD 65,000 - 85,000; Full time

Job summary

A leading healthcare institution in Los Angeles is seeking a Clinical Research Coordinator III. The role involves overseeing clinical studies, ensuring compliance with FDA guidelines, and coordinating patient recruitment. The ideal candidate holds a bachelor's degree in a related field and has four years of clinical research experience. This position offers a chance to contribute significantly to heart disease research and improve patient outcomes.

Qualifications

• High School Diploma/GED required; bachelor's degree preferred.
• Certification in Clinical Research from ACRP/SOCRA preferred.
• Four years of clinical research related experience required.

Responsibilities

• Coordinate clinical studies and screen patients for eligibility.
• Document patient conditions and protocol compliance thoroughly.
• Ensure compliance with FDA and local IRB guidelines.

Skills

Patient recruitment

Study coordination

Data collection

Regulatory compliance

Document management

Team collaboration

Education

Bachelor's degree in science, sociology or related field

Job description

Job Description

The Smidt Heart Institute reflects Cedars‑Sinai's steadfast dedication to heart disease and research innovation, giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to the Smidt Heart Institute at Cedars‑Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life‑saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars‑Sinai continues to stand at the forefront of technology, innovation and discovery, improving patient outcomes.

Are you ready to be a part of breakthrough research?

The Clinical Research Coordinator III works independently, providing study coordination including screening of potential patients for protocol eligibility, presenting non‑medical trial concepts and details, and participating in the informed consent process. The role is responsible for oversight of all studies with the group, assignment of studies to clinical research personnel and supervision of research staff. The Coordinator plans and coordinates strategies for increasing patient enrollment, improving efficiency, training of personnel, and identifying new research opportunities. The Coordinator ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Job Duties and Responsibilities

• Independent study coordination including screening of potential patients for protocol eligibility, presenting non‑medical trial concepts and details to patients, and participating in the informed consent process.
• Scheduling of patients for research visits and procedures.
• In collaboration with physicians and other medical personnel, documents thoroughly on Case Report Forms (CRFs) changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
• Maintains accurate source documentation related to all research procedures.
• Responsible for accurate and timely data collection, documentation, entry and reporting, including timely response to sponsor queries.
• Schedules and participates in monitoring and auditing activities.
• Responsible for compiling and reporting on each study, including information related to protocol activity, accrual data, workload and other research information; presents this information at regular research staff meetings.
• 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 involve other regulatory/IRB duties, budgeting duties, and assisting with patient research billing and reconciliation.
• Ensures compliance with all federal and local agencies including the FDA and local IRB.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Works with the Training and Education Coordinator to ensure all staff is properly trained and certified.
• Participates in centralized activities such as auditing, SOP development and other core research processes.
• Plans and coordinates strategies for increasing patient enrollment and/or improving clinical research efficiency.
• Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
• Identifies new research opportunities and presents them to investigators.
• Supervises other research staff.

Qualifications

• Education: High School Diploma/GED required; bachelor's degree in science, sociology or a related field preferred.
• License/Certification: Certification in Clinical Research from ACRP/SOCRA preferred.
• Experience: Four (4) years of clinical research related experience required.