Clinical Research Regulatory Specialist (Bilingual)

Medix

Doral, FLFull-time

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Qualifications

  • •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
  • •This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error
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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
  • •Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients
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