Cedars-Sinai Clinical Research Coordinator III - Pulmonary Research in Los Angeles, California
Join Cedars-Sinai and become part of a team that is at the forefront of medical advancements!
Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world.
Our Pulmonary research team are advancing pulmonary hypertension and pulmonary embolism care through research and clinical trials. The unified goal is to understand the underlying mechanisms that cause various lung diseases and ultimately translate those findings to improving patient health.
As a Clinical Research Coordinator III, you will work independently providing study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for the oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff. Plans and coordinates strategies for increasing research participant enrollment, improving efficiency, training of personnel, and identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities:
Manages the clinical research portfolio and daily operations of studies for the investigator or disease group.
Scheduling of research participants for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research participant billing and reconciliation.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict research participant confidentiality according to HIPAA regulations and applicable law.
Works with Training and Education Coordinator to ensure all staff is properly trained and certified.
Participates in centralized activities such as auditing, Standard Operating Procedure development, etc.
Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
Supervises, trains, and provides input in the performance review of other junior clinical research staff.
Department-Specific Duties and Responsibilities:
Builds and manages REDCap Databases.
Participates on call schedule if study requires it.
Coordinates interstitial lung disease (ILD) clinical trials and research projects.
Handles OnCore data for assigned trials.
BA/BS degree, required.
ACRP/SoCRA (or equivalent) certification, preferred.
5-7 years of directly related 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.