Cedars-Sinai Clinical Research Coordinator I - Regenerative Medicine Institute in Los Angeles, California
The Regenerative Medicine Institute is looking for an experienced Clinical Research Coordinator to join their research team. We are currently recruiting for over 10 protocols which include repositories, natural history studies, and Interventional trials including pharmacological and surgical approaches.
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 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).
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to patients, and participating in the informed consent process.
Scheduling of patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs).
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 the regulatory coordinator or directly with the Institutional Review Board (IRB) to submit 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 patient research billing and reconciliation.
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.
Travel may be required. Participation in lab and clinic meetings will be required. The individual will be expected to function efficiently and cooperatively with a team of faculty, research associates, clinicians and other clinic staff.
Bachelor of Science or Bachelor of Arts degree
Two (2) years minimum of related experience - prefer experience with neurological and/or neuromuscular disorders
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.