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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 to manage study coordination tasks, which include evaluating potential participants for eligibility based on study protocols, conveying non-medical trial information, and facilitating the informed consent process. This role may also involve strategizing to enhance patient enrollment, streamline operations, train staff, and discover new research avenues.

Key Responsibilities

  • Conduct independent study coordination, which encompasses screening potential participants for protocol eligibility, delivering non-medical trial information to patients, and aiding in the informed consent process.
  • Organize patient schedules for research visits and necessary procedures.
  • Collaborate with physicians and medical staff to meticulously document on Case Report Forms (CRFs) regarding patient condition changes, adverse events, concurrent medication usage, protocol adherence, and responses to study interventions.
  • Maintain precise source documentation for all research activities.
  • Ensure accurate and prompt data collection, documentation, entry, and reporting, including timely responses to sponsor inquiries.
  • Coordinate and engage in monitoring and auditing processes.
  • Compile and present study reports, including protocol activity, enrollment data, workload, and other research metrics during regular research team meetings.
  • Alert the direct supervisor regarding any concerns related to data integrity and study execution.
  • Work 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.
  • Ensure adherence to all federal and local regulations, including those set by the Food and Drug Administration (FDA) and local Institutional Review Board.
  • Uphold research practices in accordance with Good Clinical Practice (GCP) guidelines.
  • Safeguard patient confidentiality in compliance with HIPAA regulations and applicable laws.
  • May oversee the training and education of other staff members.
  • May participate in centralized functions such as auditing and 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 improvement and collaborate with team members to formulate action plans.
  • May explore new research opportunities and present findings to investigators.
  • Engage 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
  • Master's Degree strongly preferred

Licenses/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 that encompasses primary care, specialized medicine, and research initiatives. Since its inception in 1902, Cedars-Sinai has adapted to meet the diverse needs of the community, setting benchmarks in quality, innovative patient care, research, education, and community service. Today, Cedars-Sinai is acknowledged for its national leadership in transforming healthcare for the benefit of patients, influencing the future of healthcare through the development of new treatment approaches and the education of future health professionals. Additionally, Cedars-Sinai is committed to community health improvement programs aimed at supporting its most vulnerable residents.


About the Research Team

Cedars-Sinai stands as 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 environment is ideal for those seeking to work in a dynamic setting that provides the highest level of care to the Los Angeles community.