Clinical Research Associate I / Phlebotomy - Medically Associated Science & Technology Program (Mast) - Mathur Lab

Cedars Sinai Los Angeles , CA 90009

Posted 2 months ago

The Medically Associated Science and Technology (MAST) program at Cedars-Sinai is dedicated to the development of novel drugs and devices to diagnose and treat patients. This innovative program is working to develop new diagnostics and therapeutics to treat patients with illnesses related to imbalances or alterations in the microbiome. Over the last 20 years, the MAST team has made many discoveries that benefit millions of patients, and we hope to help millions more with our growing fleet of novel diagnostics and therapeutics.

As a Clinical Research Associate I in MAST, you will work directly with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate and/or implement the study and may serve as the point of contact for the external sponsors.

In this role, you will evaluate and abstract research data and ensure compliance with protocol and research objectives and will be responsible for completing case report forms, entering clinical research data, and assisting with regulatory submissions to the IRB.

Additional Job Duties & Responsibilities:

  • Provides limited patient contact as needed for study and assists with study budget and patient research billing

  • May coordinate activities, training, and education for other Clinical Research Associates

  • Complies with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care

  • Completes Case Report Forms (CRFs)

  • Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors

  • Provides supervised patient contact or patient contact for long term follow-up patients 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

  • Assists with patient research billing

  • Schedules patients for research visits and research procedures

  • Responsible for sample preparation and shipping and maintenance of study supplies and kits

  • 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 serve as the point of contact for external sponsors for select trials

  • May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications

  • May have some percent of effort in centralized activities such as auditing, Standard Operating Procedure development, etc.

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Educational Requirements:

  • Bachelor of Science or Bachelor of Arts degree required

Certification/License:

  • ACRP/SoCRA (or equivalent) certification preferred

  • California Certified Phlebotomy Technician I or Certified Phlebotomy Technician II certification, or a valid California Nursing License

Experience:

  • Two (2) years of directly related experience, or equivalent combination of education and experience

  • Working Title: Clinical Research Associate I / Phlebotomy

  • Medically Associated Science & Technology Program (MAST)

  • Mathur Lab

  • Department: Home Dept
  • Medicine Research
  • Business Entity: Academic / Research

  • City: Los Angeles

  • Job Category: Academic/Research

  • Job Specialty: Academic/Research Services

  • Position Type: Full-time

  • Shift Length: 8 hour shift

  • Shift Type: Day

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VIEW JOBS 10/3/2020 12:00:00 AM 2021-01-01T00:00 The Medically Associated Science and Technology (MAST) program at Cedars-Sinai Medical Center is dedicated to the development of novel drugs and devices to diagnose and treat patients. This innovative program is working to develop new diagnostics and therapeutics to treat patients with illnesses related to imbalances or alterations in the microbiome. Over the last 20 years, the MAST team has made many discoveries that benefit millions of patients, and we hope to help millions more with our growing fleet of novel diagnostics and therapeutics. As a Clinical Research Coordinator II (CRC II) in MAST, you will work independently to provide study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Research is focused on associates between acute gastroenteritis and disruption of gut flora, impairment of GI tract motility, and small intestinal bacterial overgrowth in the pathophysiology of irritable bowel syndrome. There is a strong focus on clinical and translational research. Projects may include, but are not limited to invetigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees. Additional Job Duties & Responsibilities: * Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. * Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; presents this information at regular research staff meetings. * May plan and coordinate strategies for increasing research participant enrollment, improving efficiency, training of personnel, or identifying new research opportunities. * Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). * Communicates project status and improvement areas with leadership in a timely manner. #Jobs-Glassdoor #Jobs-Indeed Educational Requirements: * Bachelor of Arts or Sciences degree License/Certification Requirements: * California Certified Phlebotomy Technician I or Certified Phlebotomy Technician II certification, or a valid California Nursing License * ACRP/SoCRA (or equivalent) certification preferred Experience: * Four (4) years of directly related experience minimum * Working Title: Clinical Research Coordinator II / Phlebotomy - Medically Associated Science & Technology Program (MAST) - Mathur Lab * Department: Home Dept - Medicine Research * Business Entity: Academic / Research * City: Los Angeles * Job Category: Academic/Research * Job Specialty: Research Studies/Clinical Trials * Position Type: Full-time * Shift Length: 8 hour shift * Shift Type: Day Cedars Sinai Los Angeles CA

Clinical Research Associate I / Phlebotomy - Medically Associated Science & Technology Program (Mast) - Mathur Lab

Cedars Sinai