Cedars-Sinai Clinical Research Associate I - Pancreatic and Billiary Diseases Program in Los Angeles, California
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.
Cedars-Sinai is dedicated to being the international leader in pancreatic research through its advances in prevention, early diagnosis and treatment of pancreatic cancer, pancreatitis and diabetes.
As a Clinical Research Associate I, you will work 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 (CRFs), entering clinical research data, and assisting with regulatory submissions to the Institutional Review Board (IRB). The CRA I may have limited contact with research participants as needed for study and assists with study budget and research participant billing. This role follows all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Job Duties and Responsibilities:
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Keeps meticulous records and presents results to the team.
Maintains computer database with relevant clinical information and assists with analyzing data.
Assists with clinical trial budgets, patient research billing, and schedules patients for research visits and research procedures.
Provides supervised contact with research participants or contact for long term follow-up research participants only.
Responsible for sample preparation, shipping and maintenance of study supplies and kits.
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.
Works closely with supervising research staff or directly with the IRB to submit Adverse Events, Serious Adverse Events, and Safety Letters following local and federal guidelines.
Participates in the development of data reports for internal and external reporting.
Required to be knowledgable of current GCP/IRB standard methodologies and guidelines.
- Bachelor of Science or Bachelor of Arts degree, required.
Experience and Skillset:
Clinical Research experience is highly preferred.
Understanding of general research objectives.
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.