Clinical Regulatory Specialist (Bilingual) - 250726

Benefits

Qualifications

• •Must Haves: Minimum of 3 year in clinical research regulatory and must be bilingual in English and Spanish
• •Hours: 40 hours per week, Monday-Friday, 8am-5pm, onsite in Doral, with potential of travel to Palmetto Bay location 2 times a week if needed
• •Must be Spanish-bilingual
• •Minimum of 1 year in clinical research regulatory, or 2+ years as a CRC/CRA with significant regulatory responsibilities
• •1+ years of clinical research experience with an emphasis in regulatory and QA
• •On-site in Doral, with potential travel to Palmetto Bay 1-2 times a week
• •License/certification status with CEUs, as applicable
• •Current GCP certification
• •5 more items(s)

Responsibilities

• •Performs startup activities including IRB submissions, regulatory documentation, vendor and training access, etc
• •Assists with the management of companies eRegulatory platform Complion, including creating study binders, filing startup and maintenance documents, performing quality checks, monitoring investigator and site credentials, etc
• •Completes regulatory documentation such as Financial Disclosure Forms (FDFs), Protocol Signature Pages (PSPs), FDA 1572s, and Investigative Brochure Signature Pages
• •Routes regulatory documents to research staff and investigators to obtain signatures and follow up as necessary
• •Works collaboratively with investigators and research staff to complete outstanding documents
• •Returns regulatory documents and credentials to the sponsor/CRO in a timely manner
• •Creates delegation of authority logs and adjusts as needed throughout the study duration
• •Creates training logs
• •Performs reviews of the Investigator Site Files (ISFs) for completion and accuracy
• •Gathers documents requested during Site Selection Visits (SSVs) including copies of research staff/investigators curriculum vitae (CVs), medical licenses (MLs), Good Clinical Practice (GCP) training certificates, company SOPs, site equipment calibration logs, etc
• •Creates investigator curriculum vitaes (CVs) and updates on a biannual basis or as requested
• •Obtains and maintains valid medical licenses for all investigators
• •Participates in the development of company SOPs and Guidance Documents (GDs) as needed
• •Creates and submits continuing reviews, protocol deviations, and any other ongoing IRB submissions
• •11 more items(s)