Cedars-Sinai Clinical Research Coordinator I - Center for Outcomes Research & Education (CORE)/Health Research Services in Los Angeles, California
The Cedars-Sinai Center for Outcomes Research and Education (CS-CORE) is a group of academicians that supports high quality research efforts using a health services research model. Members of the center have published extensively in the fields of healthcare quality measurements, patient-reported outcome (PRO) development, healthcare decision making, health economics and digital health sciences.
CS-CORE maintains a balance between clinical physicians with training in health services research, and rigorously trained methodologists with expertise across a wide range of techniques. This allows the center to apply advanced analytic techniques to practical, clinically oriented research projects that ultimately revolve around patients and their perspectives.
Members of CS-CORE routinely interact with social scientists, epidemiologists, health economists, psychometricians, biostatisticians, computer scientists, engineers and physicians focused in multiple medical specialties. CS-CORE scientists work closely across Cedars-Sinai and partner with a vibrant external community of university, government and healthcare institutions. This model positions CS-CORE to carry out high-level research in an efficient and effective manner across a broad spectrum of topics.
The Clinical Research Coordinator I works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. 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. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Job Duties and Responsibilities:
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Scheduling of patients for research visits and procedures.
Maintains accurate source documents related to all research procedures.
Schedules and participates in monitoring and auditing activities.
Notifies direct supervisor about concerns regarding data quality and study conduct.
Works closely with a regulatory coordinator or directly with the IRB to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May involve other regulatory / IRB duties, budgeting duties, and assisting with patient research billing and reconciliation.
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.
- Bachelor of Science or Bachelor of Arts Degree, required.
Certification and Licenses:
- ACRP/SoCRA (or equivalent) certification, preferred.
Experience and Skillset:
Two (2) years of directly related experience, required.
Ability to use discretion and maintain privacy, confidentiality or anonymity
Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations
Ability to convey and/or receive written/verbal information to/from various audiences in different formats
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.