Clinical Research Coordinator II - The Angeles Clinic & Research Institute

Cedars-Sinai Medical Center•Los Angeles, CA

About The Position

The Clinical Research Coordinator II serves as the lead coordinator for an assigned portfolio of research studies and independently establishes and coordinates the logistics and processes needed to conduct departmental research. The coordinator works with principal investigators, research participants, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and sponsor representatives to implement protocols in compliance with applicable regulatory requirements. The role establishes and completes logistical aspects of clinical research projects, including planning, projecting resource requirements, and developing systems that support protocol compliance and participant safety. It coordinates study administration, patient scheduling, procedures and laboratory visits, and completion and maintenance of consent forms, case report forms, serious adverse event documentation, and source documents. The coordinator screens and recruits potential participants, assesses protocol eligibility, presents non-medical information about trials, and supports informed consent. The role is responsible for accurate and timely data collection, documentation, entry, and reporting, including resolving sponsor and regulatory queries. It coordinates audits and study monitoring, develops and implements corrective actions, reports study activity and accrual information, and submits adverse events, serious adverse events, protocol deviations, and safety letters according to applicable guidelines. Additional duties include identifying quality improvement opportunities; planning participant enrollment and research-efficiency strategies; supporting grants, publications, presentations, and special projects; assisting with research budgets and participant billing reconciliation; and participating in meetings, conferences, and staff training. The coordinator also processes research laboratory specimens—including centrifuging, aliquoting, storing, and shipping—and monitors sponsor supplies and kits, maintains electronic supply records, and participates in monitoring and auditing activities.

Requirements

Associate degree or college diploma required.
Three years of clinical research coordination or related experience required.
Basic Life Support (BLS) certification from the American Heart Association required; the certification expiration date must be valid for at least 60 days from the start date.

Nice To Haves

Bachelor’s degree preferred.
Certification in Clinical Research from SoCRA or ACRP preferred.

Responsibilities

Lead an assigned portfolio of research studies and independently coordinate the logistics and processes required to conduct them.
Plan research projects, estimate resource requirements, and establish systems that support protocol compliance and patient safety.
Coordinate study administration, including patient scheduling for research visits, procedures, and laboratory work.
Complete and maintain consent forms, case report forms, serious adverse event documentation, and source documents.
Screen and recruit potential participants for protocol eligibility, present non-medical trial concepts and details, and support informed consent.
Collect, document, enter, and report study data accurately and promptly, and resolve sponsor or regulatory queries.
Coordinate institutional, pharmaceutical, and internal audits and third-party study monitoring; develop and implement corrective actions.
Compile and report study information, including protocol activity, accrual data, workload, and other research metrics, and present information at research staff meetings.
Submit adverse events, serious adverse events, protocol deviations, and safety letters in accordance with local and federal guidelines.
Identify quality and performance improvement opportunities and collaborate with staff on action plans.
Plan strategies to increase research participant enrollment and improve clinical research efficiency.
Provide technical support for grant proposals, publications, presentations, and special projects.
Assist with research budget development, distinguish routine care from research-related care, and support research participant billing and reconciliation.
Participate in research-related meetings, conferences, planning sessions, workshops, evaluations, seminars, and educational or administrative meetings.
Participate in training and educating new research personnel.
Process research laboratory specimens, including centrifuging, aliquoting, storing, and shipping, in accordance with protocols and laboratory procedures.
Monitor sponsor deliveries; inventory, unpack, and store kits and supplies; use supplies appropriately for specimen collection and handling; and maintain electronic supply records.
Participate in monitoring and auditing to ensure compliance, propose solutions to technical issues, and implement corrective actions.