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Job Description

This role follows a hybrid work schedule, with a minimum requirement of four days onsite per week at our Los Angeles work location. Applicants must be able to meet this onsite requirement and, if hired, must reside within a commutable distance of the work location.

The Clinical Research Coordinator III 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 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 patient 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).

This position offers an exciting opportunity to join our dynamic Gastrointestinal Disease Research Group, where you will contribute to a diverse portfolio of Phase I–III clinical trials. Our research includes pharmaceutical-sponsored, National Clinical Trials Network (NCTN), and investigator-initiated studies conducted in collaboration with internal and external partners.

Our team recently achieved a significant milestone, accruing and treating the highest number of patients on a clinical trial that contributed to FDA approval of a new medication for pancreatic ductal adenocarcinoma (PDAC). This achievement reflects our investigators’ deep commitment to advancing clinical research, improving patient care, and ensuring each study has the potential to make a meaningful impact.

You will also be supported by the Cancer Clinical Trials Office (CCTO), which is committed to strengthening and standardizing clinical research processes while providing coordinators with the training, resources, and support they need to succeed and grow in their roles.

Responsibilities: 

• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the 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) the following; changes in patient 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 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.
• Works with Training and Education Coordinator to ensure all staff is properly trained and certified.
• Participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• Plans and coordinates strategies for increasing patient enrollment, and/or improving clinical research efficiency.
• Identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• Identifies new research opportunities and presents to investigators.
• Supervises other research staff.

Department Specific Responsibilities: 

• Complete Site Feasibility Questionnaires and take on a lead role in Pre-Study/Site Qualification Calls/Visits.
• Demonstrate the ability to train, guide, and support study team staff as a subject matter expert in study execution activities. 
• Develop or contribute to the development of tools, processes, and training to enhance subject pre-screening and screening activities. May evaluate eligibility-related job aids and worksheets and provide recommendations for improvements to enhance protocol compliance.
• Evaluate study tools/plans and metrics to assess areas of non-compliance. Translate findings into the development of new tools, processes, and training to enhance the quality of study conduct.
• Create workflows and support study team members in developing workflows/processes across departments outside the Cancer Center for study logistics, including:
  • Project management during study start-up activities.
  • Identifying ancillary departments for inclusion in Site Initiation Visits (SIVs).
• Guide study team members in best practices for reporting adverse events (AEs), serious adverse events (SAEs), and deviations in line with CSMC SOCCI CCTO reporting guidelines.
• ACRP/SOCRA (or equivalent) certification required. Certification must remain current, including membership, dues, and other applicable requirements.
• Train and mentor CRC Is and IIs. Demonstrate advanced skills and knowledge with the ability to teach, coach, or supervise.
• Review labor allocations to ensure appropriate effort tracking.

Qualifications