Regulatory Specialist [Bilingual]

Rovia; Town of Florida (NY); On-site; USD 70,000 - 105,000; Full time

Job summary

Rovia Clinical Research in New York seeks a Regulatory Specialist to support day-to-day regulatory activities across the site network, ensuring compliance with ICH/GCP, sponsor requirements, and Rovia SOPs.

The role involves startup activities (IRB submissions, regulatory docs), managing the Florence eRegulatory platform, and collaborating with investigators to keep submissions and study files up to date. Travel about 10% to Palmetto Bay as needed.

Qualifications

• 1–2 years of clinical research experience with emphasis in regulatory and QA.
• Bachelor's degree preferred.
• Current GCP certification.
• Travel approximately 10% to Palmetto Bay as needed.

Responsibilities

• Performs startup activities including IRB submissions and regulatory documentation.
• Manages the Florence eRegulatory platform, including study binders and maintenance documents.
• Completes regulatory documentation such as FDFs, PSPs, FDA 1572s, and Investigator Site Files reviews.
• Routes documents to investigators for signatures and follow up.
• Collaborates with investigators and staff to finalize outstanding documents.

Skills

Medical terminology

ICH/GCP

Regulatory requirements

FDA policies

HIPAA policies

Interpersonal skills

Detail oriented

Confidentiality

Organizational skills

MS Office

Excel

Adobe Acrobat

Meet deadlines

Bilingual English/Spanish

Education

High school diploma

Bachelor's degree preferred

GCP certification

Tools

Microsoft Office

Adobe Acrobat

Microsoft Excel

Job description

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 vitae (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 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, bachelor's 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.