Clinical Research Coordinator II - The Angeles Clinic & Research Institute

Cedars-Sinai•Los Angeles, CA

1d•$66,810 - $103,563

About The Position

The Clinical Research Coordinator II serves as the lead coordinator for an assigned portfolio of research studies and works independently to establish and coordinate the logistics and processes needed to conduct departmental research. The role interacts with principal investigators, research participants, clinic and research staff, laboratory staff, medical professionals, pharmaceutical staff, and sponsor representatives to implement research protocols in compliance with applicable regulatory requirements. The coordinator plans and manages study logistics, participant recruitment and visits, research documentation and data, study reporting, audits, and corrective actions. The role also supports research budgets and billing, laboratory specimen processing and supply management, research enrollment and efficiency initiatives, and the preparation of grants, publications, and presentations. The coordinator participates in research meetings and training, and helps train new research personnel.

Requirements

Associate degree or college diploma required.
Three years of clinical research coordination or related experience.
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

Establish and complete logistical aspects of clinical research projects, including project planning, resource projections, and systems to ensure protocol compliance and patient safety.
Coordinate administrative functions of research studies, including scheduling research visits, procedures, and laboratory work, and completing and maintaining 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 the informed consent process.
Collect, document, enter, and report data accurately and on time, and resolve queries from sponsors or regulatory entities.
Coordinate institutional, pharmaceutical, and internal audits; facilitate third-party study monitoring; and design and implement corrective actions.
Compile and report study information, including protocol activity, accrual data, and workload, and present it at regular research staff meetings.
Submit adverse events, serious adverse events, protocol deviations, and safety letters on time and in accordance with local and federal guidelines.
Identify quality and performance improvement opportunities and collaborate with staff to develop action plans.
Plan and coordinate strategies to grow research participant enrollment and improve clinical research efficiency as needed.
Provide technical support for grant proposals, publications, presentations, and special projects.
Assist with research project budget development, distinguish routine care from research-related care, and assist with participant research billing and reconciliation.
Participate in research meetings and conferences, planning sessions, workshops, evaluation meetings, seminars, and educational or administrative meetings as needed or requested.
Participate in training and education of new research personnel.
Process research laboratory specimens accurately, including centrifuging, aliquoting, storing, and shipping, while applying knowledge of research protocols and laboratory procedures.
Monitor sponsor deliveries, inventory and store kits and supplies, use supplies appropriately for specimen collection and handling as required by sponsors, and maintain electronic supply records.
Participate in monitoring and auditing activities to ensure compliance, propose solutions to technical issues, and implement corrective actions.