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The Pituitary Center at Cedars-Sinai treats patients at every phase — from the newly diagnosed to those with recurrent or aggressive tumors requiring a comprehensive and multidisciplinary approach.

The Clinical Research Coordinator II works independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The incumbent will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This role is responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information, and presents this information at research staff meetings. The CRC II member may plan and coordinate strategies for increasing research participant enrollment, improving efficiency, training of personnel, or identifying new research opportunities. This position 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:

• Scheduling research visits and procedures for participants.
• In collaboration with the physician and other medical personnel, documents on Case Report Forms (CRFs) the following - changes in research participant 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 initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in compliance 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.
• 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.
• Participates in required training and education programs.
• Coordinates multi-center investigator-initiated trials.
• Works with other sites to collect and maintain regulatory documents and data reliance information.
• Develops and implements case report forms for investigator-initiated trials (IIT) in the Pituitary Center.
• Knowledgeable of regulatory guidelines for multiple trials in which our faculty members are the sponsor-investigator, including required adverse event (AE) and serious adverse (SAE) event reporting, FDA annual reporting guidelines for investigational new drug (IND) applications, clinicaltrials.gov listing requirements, and results reporting.
• Supervises and provides training to Clinical Research Associate I (CRA I).
• Works with RN to ensure research protocol adherence and medication reconciliation with research subjects.
• Develops and enforces IIT monitoring plan for multicenter NIH or FDA funded trials for which CSMC faculty act as the sponsor-investigator.
• Provides protocol training and monitoring to other study coordinators at participating multi-center sites.
• Implements center-wide recruiting efforts including contacting support groups and outside foundations to find eligible patients with rare pituitary diseases.
• Creates and analyzes data reports from Business Objects as it related to the CSMC Pituitary Tumor Registry and Surveillance Project.
• Creates electronic data capture (EDC) databases using REDCap for investigator-initiated clinical research projects.
• Assists Research Grant Specialist with creating and negotiating industry-sponsored clinical trial budgets.
• Assists Research Grant Specialist with invoicing and financial post-award monitoring/accounting of clinical research projects.
• Negotiates clinical trial agreement payment terms with industry sponsors
• Ensures FDA compliance with IIT trials conducted under Investigational New Drug (IND) applications, including initial application preparation and submission, FDA annual reports, and protocol amendment submissions.
• Works with Principal Investigators and Office of Research Compliance and Quality Improvement to ensure compliance with registration and results reporting on clinicaltrials.gov.

Education:

• High School Diploma/GED is required.
• Bachelor's degree in a Science, Sociology, or related field is preferred.

Licenses/Certifications:

• ACRP/SoCRA certification is preferred.

Experience:

• Two years of clinical research experience, required.

Physical Demands:

Lifting, standing, walking