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Pinnacle Technology · 1 day ago

Clinical Research Associate

Los Angeles, CA

Contract

Onsite

Entry Level

$28/hr - $29/hr

1+ years exp

Pinnacle Technology is seeking a Clinical Research Associate to work onsite in Los Angeles. The role involves managing research projects, ensuring compliance with regulatory requirements, and coordinating with various stakeholders throughout the research process.

ConsultingInformation TechnologyOutsourcingSoftware

Hiring Manager

Aditya Verma

Responsibilities

Submits research projects (protocols, consent forms, recruitment materials, IRB application, etc.) for human subjects’ approval

Submits appropriate internal documentation for contract execution. Maintains communication with contracting officers and sponsors of research during the budgeting and negotiating process

Develops research project budgets based on protocol requirements and client published research costs, ensuring that all anticipated costs are appropriately accommodated and that research protocol, research budget and research subject informed consent documents are consistent

Monitors study payments and generates invoices as necessary to ensure adequate funding throughout the course of the trial

Ensures timely filing of annual renewals and amendment submissions to IRB

Ensures the completion and maintenance of consent forms, case report forms, SAE’s and source documents to ensure that research is being conducted according to IRB, FDA, OHRP, HIPAA and other agency guidelines

Maintains high quality, up-to-date regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies

Completes appropriate IRB paperwork and submits internal and external Serious Adverse Events (SAEs) and INDSRs to IRB

May help coordinate and prepare for institutional, pharmaceutical and internal audits

Coordinates site feasibility visits and site initiation visits for potential studies. Completes feasibility questionnaires

Provides facility tours to visiting research sponsors, CROs, and other personnel for research-related activities

Coordinates and collaborates with internal and external investigators and participating centers in multi-center studies to achieve research goals

Participates in weekly research staff meetings

Protects rights and research data of research volunteers, including medical records, data, etc. Obtains necessary consent forms, or HIPAA information forms as needed, in research process

Performs administrative duties in a timely manner as assigned