Cedars-Sinai Clinical Research Data Coordinator II - Cancer Clinical Trials Office in Los Angeles, California
The Cancer Clinical Trials Office (CCTO) staffed by highly trained professional research personnel (research nurses, clinical research coordinators and clinical research associates), is a central office that provides the infrastructure and function for operations of Cancer Clinical Trials at Cedars-Sinai Cancer, including its medical network and health system, which at any given time has approximately 140 cancer clinical trials. CCTO resources are available to both faculty and industry sponsors to assist throughout the lifecycle of a protocol, from inception to study closeout. We are the central point of contact who coordinates with investigational pharmacy, laboratory, nursing, the National Cancer Institute (NCI) and other collaborating academic institutions.
Join our team and use your expertise with an organization known nationally for excellence in cancer research.
The Clinical Research Data Coordinator II works directly with a 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, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research 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.
In addition, the Clinical Research Data Coordinator II, will be responsible for the following:
Works with a Clinical Research Coordinator or Research Program Administrator or Research Nurse 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 patient contact or patient contact for long term follow-up patients 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.
May 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.
May coordinate activities of other associates to ensure compliance with protocol and overall clinical research objectives.
May have some percent of effort in centralized activities such as auditing, Standard Operating Procedure development, etc.
In addition the Clinical Research Data Coordinator will have the following program specific duties:
May work with the engagement lead, project lead, and study coordinators to assist the engagement team for the program.
May work remotely, on campus, and occasionally be asked to work off-site at events (under the supervision of study lead and/or study coordinators).
Attends weekly check-ins and team meetings.
Interact with participants by answering and returning telephone calls, and answering participant questions.
May be responsible for the pick-up and delivery of clinical research-related items such as biospecimens.
May work with study coordinators and team to schedule patients for research visits and procedures.
- BA/BS degree.
- ACRP/SoCRA (or equivalent) certification, preferred.
- Two (2) years of directly related experience, or equivalent combination of education and experience
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.