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Clinical Research Coordinator I - Braun Lab - Inflammatory Bowel & Immunobiology Research Institute

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Requisition # HRC0678453

Are you a passionate and dedicated research professional?

The Cedars-Sinai Inflammatory Bowel and Immunobiology Research Institute (IBIRI) is seeking a Clinical Research Coordinator I (CRC I)! IBIRI is a multidisciplinary basic, translational, and clinical research program devoted to Inflammatory Bowel Diseases. Under the direction of Dr. Jonathan Braun, the institute is seeking for a hardworking and highly motivated professional to join our team. To learn more, please visit Braun Research Lab | Cedars-Sinai.

The Clinical Research Coordinator I will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. As a Clinical Research Coordinator, you will be coordinating independent studies, screening of potential patients for protocol eligibility, presentation of non-medical trial concepts and details, and participation in the informed consent process.

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Primary Job Duties and Responsibilities:

  • In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
  • Maintains accurate source documents related to all research procedures.
  • Schedules and participates in monitoring and auditing activities.
  • Schedules patients for research visits and procedures.
  • Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
  • Notifies direct supervisor about concerns regarding data quality and study conduct.
  • Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
  • May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
  • 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.
  • Participates in required training and education programs.

Education:

  • Bachelor's Degree in Science, Sociology or related field, preferred.

Licenses and Certifications:

  • Certification In Clinical Research (SOCRA or ACRP), preferred.
  • CA Phlebotomy Certification (CPT) or willingness to obtain upon hire, preferred.

Experience and Skillset:

  • One (1) year of clinical research related experience, required. Experience with involvement in the coordination of clinical research trials, preferred.
  • Ability to use discretion and maintain privacy, confidentiality or anonymity.
  • Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.
  • Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
  • Working Title: Clinical Research Coordinator I - Braun Lab - Inflammatory Bowel & Immunobiology Research Institute
  • Department: Home Dept - Gastroenterology
  • 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 is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at Applicant_Accommodation@cshs.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Cedars-Sinai will consider for employment qualified applicants with criminal histories, in accordance with the Los Angeles Fair Chance Initiative for Hiring.

At Cedars-Sinai, we are dedicated to the safety, health and wellbeing of our patients and employees. This includes protecting our patients from communicable diseases, such as influenza (flu) and COVID-19. For this reason, we require that all new employees receive a flu vaccine based on the seasonal availability of flu vaccine (typically during September through April each year) as a condition of employment, and annually thereafter as a condition of continued employment, subject to medical exemption or religious accommodation. For the same reason, you may also be required to receive other vaccines such as COVID-19 as a condition of employment. Cedars-Sinai reserves the right to make modifications to its required list of vaccines as required by law and/or policy.

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