Clinical Research Coordinator I

2 weeks ago

Montebello, United States CEDARS-SINAI Full time
Job DescriptionGrow your career at Cedars-SinaiCedars-Sinai offers a culture of happiness, passion, and dedication. This is one of the many reasons why we rank as one of the top hospitals in California and in the nation by U.S. News & World Report.Do you have a passion for helping human kind?The Clinical Research Coordinator I will work with an interdisciplinary team of neurologists, neuropsychologists, and clinical researchers with expertise in Alzheimer's disease and related dementias. The incumbent will be responsible for overseeing studies related to the Memory Disorders Program including establishing a longitudinal clinical cohort and maintaining a clinical research registry. The CRC member will be responsible for conducting phone screenings, coordinating visits, obtaining informed consent, conducting clinical research procedures, and assisting with regulatory responsibilities. The CRC will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents study information at regular research staff meetings. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).*This is a hybrid position*Primary Duties and Responsibilities:
  • Scheduling research visits and procedures for research participants.
  • In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) the following - changes in research participant condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
  • Maintains accurate source documents related to all research procedures.
  • Schedules and participates in monitoring and auditing activities.
  • Notifies direct supervisor about concerns regarding data quality and study conduct.
  • Independently works with external study monitors and/or auditors.
  • Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
  • May involve other regulatory / IRB duties, budgeting duties, and assisting with research participant billing and reconciliation.
  • May supervise Clinical Research Associates on data entry, data query, and resolution.
  • Maintains research practices using Good Clinical Practice (GCP) guidelines.
  • Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
  • Participates in required training and education programs.
    QualificationsEducation:
    • High School Diploma/GED is required.
    • Bachelor degree in Science, Sociology or related degree is strongly preferred.Licenses/Certifications:
      • ACRP/SoCRA (or equivalent) certification is preferred.Experience:
        • One year of clinical research or coordinating clinical research trials experience is required.#Jobs-Indeed#LI-Hybrid
          About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
          About the TeamCedars-Sinai is 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 if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
          Req ID : 5892
          Working Title : Clinical Research Coordinator I - Alzheimer's and Dementia Research Program - Department of Neurology (Hybrid)
          Department : Research - Neurology
          Business Entity : Cedars-Sinai Medical Center
          Job Category : Academic / Research
          Job Specialty : Research Studies/ Clin Trial
          Overtime Status : NONEXEMPT
          Primary Shift : Day
          Shift Duration : 8 hour
          Base Pay : $23.39 - $39.76

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