Entry-Level Clinical Research Associate for Noncomplex Trials

Cedars-Sinai; Los Angeles (CA); Vor Ort; USD 65.000 - 80.000; Vollzeit

Zusammenfassung

Cedars-Sinai is seeking a Clinical Research Associate I to support noncomplex studies under supervision. The role involves data collection, CRF completion, scheduling participants, and assisting with IRB submissions.

Responsibilities include budgeting support, patient billing, sample handling, and ensuring GCP/HIPAA compliance across federal and local guidelines.

Qualifikationen

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

Aufgaben

• Assist in coordinating noncomplex studies under supervision.
• Collect and abstract clinical data; assist in data entry into sponsor EDMS/EDCs.
• Complete Case Report Forms (CRFs).
• Assist with prescreening of potential participants and scheduling visits.
• Support IRB submissions including adverse events and safety letters.
• Assist with budgeting and patient billing.
• Prepare and ship study samples and maintain supplies.
• Ensure compliance with GCP, HIPAA, FDA and local regulations.

Kenntnisse

Data collection

Prescreening

IRB submissions

Regulatory compliance

Good Clinical Practice

HIPAA

Ausbildung

High School Diploma/GED

Bachelor's Degree in Science or related field

Jobbeschreibung

Job Description

The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.

• Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.
• Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
• Completes Case Report Forms (CRFs).
• Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.
• Assists supervising staff 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 and patient research billing.
• Responsible for sample preparation and shipping and maintenance of study supplies and kits.
• Ensures compliance with protocol and overall clinical research objectives. 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.
• May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.

Qualifications

Education

• High School Diploma/GED - minimum
• Bachelor's Degree Science, Sociology or related degree. - preferred

Experience

• 1 year Clinical research related experience - preferred

Education

• High School Diploma/GED - minimum
• Bachelor's Degree Science, Sociology or related degree. - preferred

Experience

• 1 year Clinical research related experience - preferred