Clinical Research Associate I - Berman Lab

National Medical Association; Culver City (CA); On-site; Full time

Job summary

An established industry player in healthcare is seeking a Clinical Research Associate I to join their dynamic team. This role involves coordinating clinical research studies, ensuring compliance with regulatory standards, and supporting the Research Director in academic activities. You will work closely with a variety of healthcare professionals and contribute to groundbreaking research that enhances patient outcomes. If you're passionate about advancing healthcare and thrive in a fast-paced environment, this opportunity offers a chance to make a significant impact in the field.

Qualifications

• Experience in coordinating clinical research studies and ensuring compliance.
• Ability to evaluate and abstract clinical research data effectively.

Responsibilities

• Coordinate and implement clinical research studies with various stakeholders.
• Ensure compliance with federal and local regulations in research activities.

Skills

Clinical Research Coordination

Data Collection and Abstraction

Regulatory Compliance

Patient Interaction

Good Clinical Practice (GCP)

Education

High School Diploma/GED

Bachelor's Degree in Science or Sociology

Tools

Electronic Data Systems (EDCs)

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 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. Provides primary support to the Research Director on his academic activities.

• Provides primary support to the Research Director on his academic activities (seminars, lectures, meetings, writing, and editorial commitments). May include preparing first drafts, editing drafts, and submitting materials on his behalf.
• Provides other general administrative support to the Research Director, as needed.
• Works directly with imaging technician, ancillary support team, Investigators, nurses, nurse practitioners, and/or biostatistician to perform clinical research studies.
• Designs forms for data collection/abstraction. Performs data collection/abstraction.
• Retrieves non-controlled substance medication from and returns unused medication to pharmacy when medication is needed for administration to a patient by a clinic staff member.
• Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse 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 patient contact or patient contact for long term follow-up patients only.
• 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.
• 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.

Qualifications

• High School Diploma/GED required
• Bachelor's Degree in Science, Sociology or related degree preferred

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: 8131
Working Title: Clinical Research Associate I - Berman 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 - $32.86