Clinical Research Coordinator I - Smidt Heart Institute/Cardiac Surgery team

Cedars Sinai; Los Angeles (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

Cedars-Sinai's Smidt Heart Institute is seeking a Clinical Research Coordinator I to oversee patient scheduling and data documentation for research studies. This pivotal role ensures compliance with legal and ethical standards in clinical trials while contributing to groundbreaking research in heart disease. Candidates should possess a high school diploma and experience in clinical research, with potential for further education preferred.

Benefits

Healthcare benefits

Training and education programs

Collaborative work environment

Opportunity for career growth

Qualifications

• 1-year clinical research related experience required.
• ACRP/SoCRA (or equivalent) certification preferred.

Responsibilities

• Schedules patients for research visits and procedures.
• Maintains accurate source documents for research procedures.
• Ensures compliance with FDA and IRB regulations.

Skills

Data collection

Patient scheduling

Compliance with GCP

Good communication

Education

Highschool Diploma or equivalent

Bachelor's degree in science or related degree

Job description

Job Description

Grow your career at Cedars-Sinai!

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 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.

Join our team and use your skills with an organization known nationally for excellence in research!

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. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities
? 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.
? 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.
? 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.
? 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

Educational Requirements:

- Highschool Diploma or equivalent experience required
- Bachelor's degree in science, sociology or related degree preferred

Licenses:

ACRP/SoCRA (or equivalent) certification preferred.

Experience:

1-year clinical research related experience required

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 : HRC1394612
Working Title : Clinical Research Coordinator I - Smidt Heart Institute/Cardiac Surgery team
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 : $23.39 - $39.76