Clinical Research Associate II

3 weeks ago


Fresno, United States Cedars-Sinai Full time
Job Description

Come join our team

The Clinical Research Associate II works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse, or Principal Investigator to coordinate and/or implement the study and may serve as the point of contact for the external sponsors. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact with research participants as needed for study and assist with study budget and patient research participant research billing. In addition, the CRA II may coordinate activities, training, and education for other Clinical Research Associates. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

What are the Primary Duties and Responsibilities?

  • Works with a Clinical Research Coordinator,Research Program Administrator, Research Nurse, or Principal Investigator to coordinate/implement study.
  • Evaluates and abstracts clinical research data from source documents.
  • Completes Case Report Forms (CRFs).
  • Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
  • Provides supervised contact with research participants or contact for long term follow-up research participants only.
  • Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines
  • Assists with clinical trial budgets.
  • Schedules research participants for research visits and research procedures.
  • Responsible for sample preparation and shipping and maintenance of study supplies and kits.
  • Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
  • Participates in required training and education programs. May be involved in training and education of other Clinical Research Associates.
  • Serves as the point of contact for external sponsors for select trials.
  • Coordinates activities of other associates to ensure compliance with protocol and overall clinical research objectives.
  • Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
  • May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications

Qualifications

Educational Requirements:

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

Experience Requirements:

  • One (1) year of clinical research related experience required

License & Certification Requirements:

  • Certification in Clinical Research (SOCRA or ACRP) preferred

About Us Cedars-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 Team Cedars-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 : 4375
Working Title : Clinical Research Associate II - Obstetrics & Gynecology - Minimally Invasive Gynecologic Surgery (Full-Time, Hybrid)
Department : Womens Cancer Program - WCP
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 : $21.26 - $36.14

  • Fresno, California, United States CEDARS-SINAI Full time

    Job OverviewJoin 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...


  • Fresno, California, United States CEDARS-SINAI Full time

    Job SummaryCedars-Sinai is seeking a highly skilled Clinical Research Coordinator II to join our Pediatric Neonatology team. As a key member of our research team, you will be responsible for coordinating clinical trials, managing research data, and ensuring compliance with regulatory requirements.Key ResponsibilitiesStudy Coordination: Independently...


  • FRESNO, United States CEDARS-SINAI Full time

    Job DescriptionWhen the work you do every single day has a crucial impact on the lives of others, every effort, every detail, and every second matters. This shared culture of happiness, passion, and dedication pulses through Cedars-Sinai. With a team focused on effective pain management and quick recovery, Cedars-Sinai has been ranked as the No. 1 hospital...


  • Fresno, United States CEDARS-SINAI Full time

    Job DescriptionCome join our team!The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms,...


  • FRESNO, United States CEDARS-SINAI Full time

    Job Description Come join our team! The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report...


  • FRESNO, United States CEDARS-SINAI Full time

    Job DescriptionCome join our team!The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms,...


  • Fresno, California, United States Cedars-Sinai Full time

    Position OverviewTransformative healthcare starts with researchWe encourage you to explore this exceptional opportunity to impact the lives of numerous patients by collaborating in the research domain.The Clinical Research Funding Coordinator will collaborate with the Principal Investigator (PI), research coordinators, and additional research personnel to...

  • Research Associate

    2 weeks ago


    Fresno, California, United States WestCare Full time

    Position Overview:The Research Assistant will play a vital role within the Research and Evaluation team, tasked with executing the Research and Evaluation strategy for WestCare's Adult Reentry Warm Hand Off and Rental Assistance initiatives. The ideal candidate should possess an understanding of diverse cultural backgrounds, socio-economic factors, and...


  • Fresno, United States Clinical Search Group, LLC Full time

    Job DescriptionJob DescriptionGreat opportunity for a Registered Nurse or possibly at Registered Dietitian. My client is the most progressive companies in the medical device marketplace. They have won numerous awards on their design of their Exclusive Medical Device used in the treatment of patients that suffer from Type I and Type II Diabetes. The...

  • Clinical Nurse II

    2 weeks ago


    Fresno, California, United States Cedars-Sinai Full time

    Become a vital part of our healthcare team at Cedars-Sinai Medical CenterWe are seeking a committed Clinical Nurse to join our Neurology department. In this role, you will provide exceptional care to patients experiencing a range of neurological disorders, including but not limited to craniotomies, brain tumors, and strokes.Administer prescribed medications...

  • Counselor II

    2 months ago


    Fresno, United States Amity Foundation Full time

    This position is located onsite at Pleasant Valley State Prison (PVSP) in Coalinga, CA. Amity Foundation , an internationally acclaimed Teaching and Therapeutic Community, is seeking compassionate and enthusiastic individuals with a desire to teach, learn and join our community as a Certified Substance Abuse Counselor II at our in-prison facilities. This...


  • FRESNO, United States CEDARS-SINAI Full time

    Job DescriptionThe Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and...


  • Fresno, United States Cedars-Sinai Full time

    Job Description The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and...

  • Counselor II

    3 months ago


    Fresno, United States Amity Foundation Full time

    Job DescriptionJob DescriptionThis position is located onsite at Pleasant Valley State Prison (PVSP) in Coalinga, CA.Amity Foundation, an internationally acclaimed Teaching and Therapeutic Community, is seeking compassionate and enthusiastic individuals with a desire to teach, learn and join our community as a Certified Substance Abuse Counselor II at our...


  • Fresno, California, United States Vitalent Full time

    Vitalent is looking for a dedicated per diem Registered Nurse to become a vital part of our Clinical Research Team. We offer comprehensive training and provide all necessary personal protective equipment (PPE) for your safety and comfort.Key Responsibilities:Monitor and record vital signsAssess for any recent hospital admissionsReview and document...


  • FRESNO, United States CEDARS-SINAI Full time

    Job DescriptionCome join our team!The Clinical Research Specialist I provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May...


  • Fresno, United States CEDARS-SINAI Full time

    Job DescriptionCome join our team!The Clinical Research Specialist I provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May...

  • Staff Accountant II

    3 weeks ago


    Fresno, United States PrideStaff Full time

    Position: Staff Accountant II - Location: Fresno, CA - Areas of Responsibility: We are searching for a self-motivated, highly driven individual to join our fast-paced team environment. The Staff Accountant II will report directly to the Associations Staff Accountant, Accountant, Staff, Accounting, Financial, Monitoring, Staffing


  • Fresno, California, United States CA High Speed Rail Authority Full time

    Position Overview Under the supervision of the Staff Services Manager II (SSM II) at the Central Valley Regional Office, the Associate Governmental Program Analyst (AGPA) or Outreach Specialist is tasked with executing various responsibilities related to the Authority's extensive stakeholder engagement and public outreach initiatives in the Central Valley....


  • Fresno, CA, United States CEDARS-SINAI Full time

    The Clinical Research Coordinator I works independently providing study coordination, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting...