Clinical Research Specialist II

2 weeks ago

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

Position Summary

The Clinical Research Coordinator II operates autonomously to manage study operations, which includes evaluating potential participants for eligibility based on study protocols, conveying non-medical trial information, and engaging in the informed consent process. This role may also involve strategizing to enhance patient recruitment, boost operational efficiency, train staff, and explore new research avenues.

Key Responsibilities

  • Oversee independent study management, including assessing potential participants for protocol eligibility, explaining non-medical trial information to candidates, and facilitating the informed consent process.
  • Coordinate patient scheduling for research appointments and procedures.
  • In collaboration with medical personnel, accurately document patient condition changes, adverse events, concurrent 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.
  • Organize and engage in monitoring and auditing processes.
  • Compile and present study reports detailing protocol activities, enrollment statistics, workload, and other relevant research data during regular team meetings.
  • Alert supervisors regarding any concerns related to data integrity and study execution.
  • Collaborate 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 local IRB.
  • Uphold research standards in accordance with Good Clinical Practice (GCP) guidelines.
  • Maintain strict confidentiality of patient information in compliance with HIPAA regulations and applicable laws.
  • May facilitate training and educational initiatives for other staff members.
  • May participate in centralized functions 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 team members to formulate action plans for improvement.
  • May discover 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. Established in 1902, Cedars-Sinai has continuously 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 renowned for its national leadership in advancing healthcare for the benefit of patients and is committed to shaping the future of healthcare through the development of new treatment methodologies and the education of future health professionals.


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 the opportunity to work in a dynamic environment that provides the highest level of care to those in need.

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