Clinical Research Specialist II

2 months ago

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

Position Summary

The Clinical Research Coordinator II operates autonomously, managing the coordination of clinical studies. This includes evaluating potential participants for eligibility based on study protocols, explaining non-medical trial concepts, and facilitating the informed consent process. The role may also involve strategizing to enhance patient enrollment, streamline operations, train staff, and explore new research avenues.

Key Responsibilities

  • Conduct independent study coordination, including evaluating potential participants for eligibility, conveying non-medical trial concepts to patients, and overseeing the informed consent process.
  • Arrange appointments for research visits and procedures.
  • Collaborate with physicians and medical staff to accurately document patient conditions, adverse events, medication usage, protocol adherence, and responses to study interventions on Case Report Forms (CRFs).
  • Maintain precise source documentation for all research activities.
  • Ensure timely and accurate data collection, documentation, entry, and reporting, including prompt responses to sponsor inquiries.
  • Coordinate and participate in monitoring and auditing processes.
  • Compile and present study reports, including protocol activity, patient enrollment data, workload, and other relevant research information during regular team meetings.
  • Alert supervisors to any concerns regarding data integrity and study execution.
  • Work closely with regulatory coordinators or directly with the Institutional Review Board (IRB) to report 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.
  • Ensure adherence to all federal and local regulations, including those set by the Food and Drug Administration (FDA) and the local Institutional Review Board.
  • Uphold research practices in accordance with Good Clinical Practice (GCP) guidelines.
  • Maintain strict confidentiality of patient information in line with HIPAA regulations and applicable laws.
  • May oversee the training and education of other staff members.
  • May engage in centralized activities such as auditing and the development of Standard Operating Procedures.
  • May devise and implement strategies to boost patient enrollment and enhance clinical research efficiency.
  • May identify opportunities for quality and performance improvements and collaborate with team members to create action plans.
  • May discover new research opportunities and present them to investigators.
  • Participate in mandatory training and educational programs.

Qualifications

Educational Background:

  • High School Diploma/GED required
  • Bachelor's Degree in a relevant field such as Science or Sociology preferred
  • Master's Degree strongly preferred

Certifications:

  • SOCRA or ACRP certification preferred

Experience:

  • Minimum of two (2) years of experience in clinical research required

About Cedars-Sinai

Cedars-Sinai is recognized as a leader in delivering high-quality healthcare, encompassing primary care, specialized medicine, and innovative research. Established in 1902, Cedars-Sinai has continually adapted to meet the diverse needs of the community, setting benchmarks in quality and pioneering patient care, research, education, and community service. Today, Cedars-Sinai is acknowledged for its national leadership in transforming healthcare for the benefit of patients, impacting the future of healthcare through the development of new treatment approaches and the education of future health professionals. The organization is also committed to enhancing community health through initiatives aimed at improving the well-being of its most vulnerable residents.


About the Research Team

Cedars-Sinai is one of the largest nonprofit academic medical centers in the United States, featuring 886 licensed beds, 2,100 physicians, 2,800 nurses, and thousands of other healthcare professionals and staff. This position offers an opportunity to work in a dynamic environment that provides the highest level of care to those in need.

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