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Cedars-Sinai Clinical Research Coordinator I - Pulmonary in Los Angeles, California

Do you have a passion for helping human kind?

The Pulmonary Research team at the Cedars-Sinai Women's Guild Lung Institute comprises a group of world-class researchers whose combined interests span multiple disciplines. The unified goal of this team is to understand the underlying mechanisms that cause various lung diseases and ultimately translate those findings to improve patient health.

As a Clinical Research Coordinator I in the Pulmonary Clinical Research team, you will work independently providing 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. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. You will also be responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. You will present this information at regular research staff meetings. You will ensure compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Primary Duties and Responsibilities:

  • Independent study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details to the research participants, and participating in the informed consent process.

  • Scheduling of research participants for research visits and procedures.

  • In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.

  • Maintains accurate source documents related to all research procedures.

  • Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.

  • Schedules and participates in monitoring and auditing activities.

  • 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.

  • 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 / Institutional Review Board duties, budgeting duties, and assisting with research participant billing and reconciliation.

  • May supervise Clinical Research Associates on data entry, data query, and resolution.

  • 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 research participant confidentiality according to HIPAA regulations and applicable law.

  • Participates in required training and education programs.

Education:

  • High School Diploma/GED, required

  • Bachelor's Degree, preferred

Licenses :

  • Certification In Clinical Research SOCRA or ACRP certification, preferred

Experience :

  • 1 year of clinical research related experience, required

  • 1 year involvement in coordiantion of clinical research trials, highly preferred

Physical Demands :

Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.

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.

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