Clinical Research Coordinator II - Pancreatic Research Program

Cedars-Sinai•Los Angeles, CA

6h•$58,864 - $100,069•Onsite

About The Position

The Clinical Research Coordinator II works independently providing study coordination in support of The Pancreatic Research Program's multidisciplinary team's larger goal of enhancing treatments and outcomes for pancreatic cancer, pancreatitis, and diabetes patients. This position is responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is also responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. The incumbent is expected to present information at research staff meeting, may plan and coordinate strategies for increasing patient enrollment, improving efficiency, and training of personnel. The incumbent ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Requirements

Accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.
Compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information.
Presenting information at research staff meeting.
Planning and coordinating strategies for increasing patient enrollment, improving efficiency, and training of personnel.
Ensuring compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Maintaining research practices using Good Clinical Practice (GCP) guidelines.
Maintaining strict patient confidentiality according to HIPAA regulations and applicable law.

Nice To Haves

May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.

Responsibilities

Screening of patients for protocol eligibility, presenting non-medical trial concepts and details.
Schedules patients for research visits and procedures.
In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, and response to study drug.
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 Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board 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.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
Participates in required training and education programs.