Clinical Research Associate I – Smidt Heart Institute - LosAngeles, United States - Cedars Sinai Medical Center

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 assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist 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

• 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.

Educational Requirements:

– Highschool diploma/GED required
– Bachelor's degree in science preferred

Licenses: N/A

Experience:

1 year clinical research related 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

Working Title:

Clinical Research Associate I – Smidt Heart Institute

Department:

Heart Institute Operations

Business Entity:

Cedars-Sinai Medical Center

Job Category:

Academic/Research

Job Specialty:

Research Studies/Clinical Trials

Position Type:

Full-time

Shift Length:

8 hour shift

Shift Type:

Day

Base Pay:

$19.50 – $29.87

Cedars-Sinai is an Equal Employment Opportunity employer.

Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.

At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu) and COVID-19. For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.

Cedars – Sinai's EEO and AA Policy Statement

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