Clinical Research Associate jobs in United States
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APR Consulting · 13 hours ago

Clinical Research Associate

APR Consulting, Inc. is seeking a Clinical Research Associate to work onsite in Los Angeles. The role involves submitting research projects for approval, maintaining communication with sponsors, developing project budgets, and ensuring compliance with regulatory guidelines.

ConsultingCRMHuman ResourcesInformation TechnologySmall and Medium BusinessesStaffing Agency

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 Cedars-Sinai 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

Qualification

Clinical research experienceOncology research experiencePharmaceutical research experienceHigh School Diploma/GEDBachelor's degree

Required

High School Diploma/GED required
1 year Clinical research related experience required

Preferred

Bachelor's degree preferred
Chemo, Oncology, or pharmaceutical research experience
Interested in temp to perm

Company

APR Consulting

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APR Consulting is a nationally recognized, award-winning provider of talent acquisition and workforce solutions, helping organizations simplify, scale, and optimize their operations.

Funding

Current Stage
Growth Stage

Leadership Team

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Aaron Stone
Chief Operating Officer
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Company data provided by crunchbase