Cedars-Sinai Clinical Research Associate II - Part Time - SOCCI in Los Angeles, California
The Clinical Research Associate II works directly with a Clinical
Research Coordinator, Research Program Administrator, Research Nurse, or
Principal Investigator 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, entering clinical research data, and assist with regulatory
submissions to the IRB. Provides
limited contact with research
participants as needed for study and assist with study budget and research participant billing.
In addition, the CRA II may coordinate activities, training, and
education for other Clinical Research Associates. This role will comply with all federal,
local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study
and patient care.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Works with a
Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to
abstracts clinical research data from source documents.
with protocol and overall clinical research objectives.
Report Forms (CRFs).
research data into Electronic Data Systems (EDCs) that are provided by the
contact with research participants or contact for long term follow-up research
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.
clinical trial budgets.
Assists with patient
participants for research visits and research procedures.
sample preparation and shipping and maintenance of study supplies and kits.
with all federal and local agencies including the Food and Drug Administration
(FDA) and local Institutional Review Board.
practices using Good Clinical Practice (GCP) guidelines.
patient confidentiality according to HIPAA regulations and applicable law.
required training and education programs.
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 be involved in training and education of other Clinical Research
activities of other associates to ensure compliance with protocol and overall
clinical research objectives.
Participates in centralized
activities such as auditing, Standard Operating Procedure development, etc.
DEPARTMENT AND/OR UNIT SPECIFIC - ESSENTIAL JOB RESPONSIBILITIES:
Evaluates and abstracts data to support the Endocrine
and Head and Neck research projects.
Maintains and troubleshoots program patient databases including
reporting and auditing.
Supports the investigators with preparation and submission of new
protocols and processing regulatory paperwork and communicating responses as
Prepares program data in various
formats for evaluation by investigators or presentations by investigators.
ACRP/SoCRA (or equivalent) certification preferred
Two (2) years of directly related experience
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.