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Clinical Research Specialist II

2 months ago

Fresno, California, United States CEDARS-SINAI Full time
Job Overview

Join our dedicated team at Cedars-Sinai.

The Clinical Research Specialist II operates autonomously, managing study coordination which includes evaluating potential participants for protocol suitability, conveying non-medical trial information, and engaging in the informed consent process.

This role may involve strategizing to enhance patient enrollment, boost operational efficiency, train staff, or discover new research avenues.
Key Responsibilities

Independent study management encompassing the evaluation of potential participants for protocol eligibility, conveying non-medical trial information to patients, and facilitating the informed consent process.

Organizes patient schedules for research appointments and procedures.

In collaboration with medical professionals, meticulously documents on Case Report Forms (CRFs) the following: changes in patient condition, adverse events, concomitant medication usage, protocol adherence, and responses to study medication.

Maintains precise source documents related to all research activities.
Accountable for timely and accurate data collection, documentation, entry, and reporting, including prompt responses to sponsor inquiries.
Coordinates and participates in monitoring and auditing processes.

Responsible for compiling and reporting on each study, including details related to protocol activity, enrollment data, workload, and other research metrics; presents this information at regular research team meetings.

Alerts direct supervisor regarding concerns about data integrity and study execution.

Collaborates closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit reports on Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in compliance with local and federal regulations.

May undertake additional regulatory duties, budgeting responsibilities, and assist with patient research billing and reconciliation.
Ensures adherence to all federal and local regulations, including those set by the Food and Drug Administration (FDA) and local Institutional Review Board.
Upholds research practices in line with Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality in accordance with HIPAA regulations and applicable laws.
May oversee training and education for other personnel.
May engage in centralized activities such as auditing and the development of Standard Operating Procedures.
May devise and implement strategies to enhance patient enrollment and/or improve clinical research efficiency.

May identify opportunities for quality and performance enhancement and collaborate with staff to formulate action plans for improvement.

May discover new research opportunities and present them to investigators.
Participates in mandatory training and educational programs.
Qualifications

Educational Background:

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

Licenses/Certifications:

SOCRA or ACRP certification preferred

Experience:

Two (2) years of experience in clinical research is required.

About Cedars-Sinai

Cedars-Sinai is a prominent institution in delivering high-quality healthcare, encompassing primary care, specialized medicine, and research.

Since its inception, Cedars-Sinai has adapted to meet the needs of a diverse population, setting benchmarks in quality and innovative patient care, research, education, and community service.

Today, Cedars-Sinai is recognized for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai influences the future of healthcare by developing novel treatment approaches and educating the next generation of health professionals. Furthermore, Cedars-Sinai is committed to community initiatives that enhance the health of its most vulnerable residents.
About the Team


Cedars-Sinai stands as 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 opportunity if you seek to work in a dynamic environment that provides the highest level of care to individuals in need.