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

coordinate/implement study.

Evaluates and

abstracts clinical research data from source documents.

Ensures compliance

with protocol and overall clinical research objectives.

Completes Case

Report Forms (CRFs).

Enters clinical

research data into Electronic Data Systems (EDCs) that are provided by the

sponsors.

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 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.

Assists with

clinical trial budgets.

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.

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.

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

Associates.

Coordinates

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

needed.

Prepares program data in various

formats for evaluation by investigators or presentations by investigators.

EDUCATIONAL REQUIREMENTS:

BA/BS degree

LICENSE/CERTIFICATION REQUIREMENTS:

ACRP/SoCRA (or equivalent) certification preferred

EXPERIENCE:

Two (2) years of directly related experience

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.