Cedars-Sinai Clin Research Assoc I/CPT PRDM/Cheng Lab in Los Angeles, California
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study. 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 assists with study budget and research participant billing. 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 patients 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 including CSMC phlebotomy-specific clinical oversight which encompasses initial training, monthly assessments, six-month assessments, and annual assessments.
Performs phlebotomy services according to CSMC policies and procedures.
Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated
Identifies patients and patient samples by strict adherence to established procedures; labels samples accurately and completely.
Reports test results to appropriate individuals and exercises professional discretion with patient information.
- Bachelor of Arts Or Bachelor of Science degree Or Equivalent combination of education & experience.
- California Certified Phlebotomy Technician I or Certified Phlebotomy Technician II certification
Understanding of general clinical research objectives.
Clinical research experience, preferred
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.
Working Title: Clin Research Assoc I/CPT PRDM/Cheng Lab
Department: Heart Institute Operations
Business Entity: Academic / Research
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Per Diem
Shift Length: 8 hour shift
Shift Type: Day
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.