When 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.

We invite you to consider this phenomenal opportunity!

As a Clinical Research Associate II, you will work directly with a Principal Investigator, 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. This role evaluates and abstracts research data, and ensures compliance with protocol and research objectives. Position is responsible for completing case report forms (CRFs) and entering clinical research data. The CRA II provides limited patient contact with research participants as needed for study and assists with study budget and patient research participant research billing. In addition, the incumbent will coordinate activities (meetings, conference calls, travel, etc.), training, and education for other internal and external research team members. Responsible for drafting research Standard Operating Procedures. This role will comply with all federal, local, FDA, IRB, IACUC, and HIPAA guidelines and regulations pertaining to the study, animal welfare, and patient care. The CRA II might conduct genotyping and wet lab procedures for preclinical studies.

Primary Job Duties and Responsibilities:

• 
  Completes Case Report Forms (CRFs) and Research Report Forms (RRFs).
• 
  Enters clinical and basic research data into internal or external database systems provided.
• 
  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 Institutional Animal Care and Use Committee (IACUC) and works closely with supervising research staff or directly with the IRB or IACUS (as appropriate) to submit Adverse Events, Serious Adverse Events, Safety Letters in accordance, or animal welfare concerns in accordance with local and federal guidelines.
• 
  Assists with clinical trial and basic research budget preparation. Assists with patient research billing.
• 
  Schedules research participants 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) and Good Laboratory Practice (GLP) guidelines.
• 
  Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.
• 
  May participate in the development of Investigator initiated trials for Investigational New Drug applications and/or Device applications.
• 
  May be involved in training and education of other Clinical Research Associates.
• 
  Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.

Department-Specific Duties:

• 
  May create clinical databases, such as RedCap, and develop CRFs.
• 
  May participate in writing clinical trial protocols and serve as resource for upcoming new clinical trials.
• 
  Required to learn and use CSMC systems related to clinical research study management.
• 
  Ensures compliance with central IRBs or IRBs of record. Schedules study related meetings.
• 
  Records and distributes meeting minutes.
• 
  Assists in the development of project proposals, grant submissions to external sponsors, and design of clinical trials.
• 
  Assists in the development of interventions for use/comparison in upcoming clinical trials through research literature searches.
• 
  May assist in manuscript and grant preparation/writing.

Education:

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

Licenses/Certifications:

• 
  ACRP/SoCRA certification is preferred.

Experience and Skills:

• 
  1+ years of clinical research experience is required.
• 
  Clinical research coordination and bench research experience in wet lab is preferred.
• 
  Must have strong MS Office digital literacy, conduct Internet searches, and ability to become proficient using related organizational and sponsor software programs.

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.