Regulatory Specialist [Bilingual]

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

About Us

At Rovia Clinical Research, we’re on a mission to bring innovative treatments to patients, improving the health and lives of our local patient communities. We believe in building a workplace where people feel supported, valued, and excited to grow their careers. Whether you’re just starting out or looking for a new path, you’ll be part of a team that truly works together and makes an impact. Our team is driven by our core values: People First, Humility, Integrity, One Team, and Results Accountability.

Position Summary

The Regulatory Specialist will work as an integral member of the research staff by maintaining day-to-day regulatory tasks within the site network, assisting with the execution of clinical studies in accordance with the protocol, contract scope of work, ICH/GCP, sponsor, CRO, Rovia SOPs, and any relevant local guidelines and regulations.

About Us

At Rovia Clinical Research, we’re on a mission to bring innovative treatments to patients, improving the health and lives of our local patient communities. We believe in building a workplace where people feel supported, valued, and excited to grow their careers. Whether you’re just starting out or looking for a new path, you’ll be part of a team that truly works together and makes an impact. Our team is driven by our core values: People First, Humility, Integrity, One Team, and Results Accountability.

Position Summary

The Regulatory Specialist will work as an integral member of the research staff by maintaining day-to-day regulatory tasks within the site network, assisting with the execution of clinical studies in accordance with the protocol, contract scope of work, ICH/GCP, sponsor, CRO, Rovia SOPs, and any relevant local guidelines and regulations.

Key Responsibilities

• Performs startup activities including IRB submissions, regulatory documentation, vendor and training access, etc.


• Assists with the management of Rovia's eRegulatory platform Florence, 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, Rovia 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.


• May perform other job-related duties as requested or required.

Skills/Abilities

• Sound knowledge of medical terminology.


• Sound knowledge of ICH/GCP, Regulatory requirements, FDA and HIPAA policies and practices.


• Excellent interpersonal skills to interact effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors, and sponsors.


• Meticulous attention to detail.


• Ability to maintain confidentiality.


• Strong written communication skills.


• Strong organizational skills.


• Proficient in the use of Microsoft Office, Microsoft Excel, and Adobe Acrobat.


• Ability to meet multiple and changing deadlines


• Ability to consult numerous sources for information to prepare documents.


• Fluent in spoken and written English and Spanish.

Education/Experience

• High school diploma required, bachelors degree preferred.


• 1-2 years of clinical research experience with an emphasis in regulatory and QA.


• License/certification status with CEUs, as applicable.


• Current GCP certification.

Position will require ~10% travel to Palmetto Bay as needed.