Clinical Research Regulatory Specialist

Rovia Clinical Research

About The Position

The Clinical Research Regulatory Specialist is an integral member of the research staff and maintains day-to-day regulatory tasks within the site network. The role assists with executing clinical studies in accordance with the protocol, contract scope of work, ICH/GCP, sponsor and CRO requirements, Rovia SOPs, and relevant local guidelines and regulations. The specialist supports study startup and ongoing regulatory activities, maintains study records in Rovia’s Florence eRegulatory platform, coordinates document completion and signatures, and helps ensure site files and investigator credentials are current, complete, and accurate. The role also contributes to company SOPs and Guidance Documents and performs other job-related duties as requested or required.

Requirements

High school diploma required.
1–2 years of clinical research experience, with an emphasis in regulatory and quality assurance.
Current GCP certification.
License or certification status with continuing education units, as applicable.
Sound knowledge of medical terminology.
Sound knowledge of ICH/GCP, regulatory requirements, and 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 and ability to maintain confidentiality.
Strong written communication and organizational skills.
Proficiency with Microsoft Office, Microsoft Excel, and Adobe Acrobat.
Ability to meet multiple and changing deadlines.
Ability to consult numerous sources of information to prepare documents.
Fluency in spoken and written English.

Nice To Haves

Bachelor’s degree preferred.

Responsibilities

Perform study startup activities, including IRB submissions, regulatory documentation, and arranging vendor and training access.
Assist with management of Rovia’s Florence eRegulatory platform by creating study binders, filing startup and maintenance documents, performing quality checks, and monitoring investigator and site credentials.
Complete regulatory documentation, including Financial Disclosure Forms, Protocol Signature Pages, FDA 1572s, and Investigator Brochure Signature Pages.
Route regulatory documents to research staff and investigators for signatures and follow up as needed.
Collaborate with investigators and research staff to complete outstanding documents.
Return regulatory documents and credentials to sponsors and CROs in a timely manner.
Create and update delegation of authority logs throughout the study.
Create training logs.
Review Investigator Site Files for completion and accuracy.
Gather documents requested during Site Selection Visits, including staff and investigator CVs, medical licenses, GCP training certificates, Rovia SOPs, and site equipment calibration logs.
Create investigator CVs and update them biannually or as requested.
Obtain and maintain valid medical licenses for all investigators.
Participate in developing company SOPs and Guidance Documents as needed.
Create and submit continuing reviews, protocol deviations, and other ongoing IRB submissions.
Perform other job-related duties as requested or required.