Clinical Regulatory Specialist – Impactful Trials

Rovia Clinical Research; Miami (FL); On-site; USD 65,000 - 90,000; Full time

Job summary

Rovia Clinical Research in Florida is seeking a Regulatory Specialist to maintain day-to-day regulatory tasks within the site network and assist with clinical studies in accordance with ICH/GCP, sponsor, CRO, and local guidelines.

The role requires knowledge of medical terminology and regulatory requirements, plus strong interpersonal and written communication skills. Travel ~10% to Palmetto Bay may be required.

Qualifications

• Strong knowledge of ICH/GCP and regulatory requirements.
• Experience with FDA and HIPAA policies.
• Excellent interpersonal and written communication skills.
• Meticulous attention to detail and ability to maintain confidentiality.
• Ability to manage multiple deadlines and coordinate with investigators.

Responsibilities

• Performs startup activities including IRB submissions and regulatory documentation.
• Manages regulatory documentation and study binders.
• Completes regulatory forms such as FDA 1572s and ISF reviews.
• Routes regulatory documents for signatures and follow-ups.
• Works with investigators and staff to complete outstanding documents.
• Returns documents and credentials to sponsor/CRO in a timely manner.
• Creates delegation of authority logs and training logs.
• Gathers ISF documents for Site Selection Visits (SSVs) and updates CVs.
• Updates investigator CVs biannually or as requested.
• Obtains and maintains valid medical licenses for investigators.
• Participates in SOPs and Guidance Documents as needed.
• Performs other duties as requested.

Skills

Medical terminology

ICH/GCP

Regulatory requirements

FDA policies

HIPAA

Interpersonal skills

Attention to detail

Confidentiality

Written communication

Organizational skills

MS Office

Excel

Adobe Acrobat

Bilingual English/Spanish

Education

High school diploma

Bachelor's degree

Tools

Microsoft Office

Microsoft Excel

Adobe Acrobat

eRegulatory Florence

Job description

Rovia Clinical Research in Florida is seeking a Regulatory Specialist to maintain day-to-day regulatory tasks within the site network and assist with clinical studies in accordance with ICH/GCP, sponsor, CRO, and local guidelines.

The role requires knowledge of medical terminology and regulatory requirements, plus strong interpersonal and written communication skills. Travel ~10% to Palmetto Bay may be required.