Cedars-Sinai Clinical Research Coordinator II in Los Angeles, California

The Regenerative Medicine Institute is involved in many clinical research activities including data and tissue repositories, natural history studies, and sponsored interventional clinical trials of all phases.

The Clinical Research Coordinator II works under the supervision of Institute's Research Program Administrator and the principle investigator providing study coordination including 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 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; present this 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).

  • Study coordination includes screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.

  • Scheduling of patients 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 patient 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; present this information at regular research staff meetings.

  • Notifies direct supervisor about concerns regarding data quality and study conduct.

  • Works closely 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 involve 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 law.

  • Participates in required training and education programs.

  • This position is specifically for the Neuromuscular Medicine group working with patient populations including but not limited to Amyotrophic lateral sclerosis, Charcot-Marie-Tooth, Myasthenia Gravis, and Neuropathy.

Educational Requirements:

  • BA or BS degree required

License/Certification Requirements:

  • ACRP/SoCRA (or equivalent) certification preferred but not required

Experience Requirements:

  • Two (2) years of directly related experience

Physical Demands:

  • Excellent communication and interpersonal skills required. 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.