Spanish fluency required: This role requires expert-level fluency in Spanish, including the ability to read, write, and speak, as you will be working closely with a Spanish-speaking population.

Flexible schedule: We are open to both full-time and part-time availability, depending on the needs of the selected candidate.

Outreach travel: The position includes occasional day trips to Bakersfield for outreach activities with the team.

Transportation: While having your own vehicle is a plus, it is not required-transportation will be provided for outreach travel.

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.

Requirements:

• High School Diploma/GED required.

Preferred:

• Bachelor's Degree preferred.
• 1 year Clinical research related experience preferred.

Spanish fluency required: This role requires expert-level fluency in Spanish, including the ability to read, write, and speak, as you will be working closely with a Spanish-speaking population.

Flexible schedule: We are open to both full-time and part-time availability, depending on the needs of the selected candidate.

Outreach travel: The position includes occasional day trips to Bakersfield for outreach activities with the team.

Transportation: While having your own vehicle is a plus, it is not required-transportation will be provided for outreach travel.