Clinical Research Regulatory Specialist

About this role

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 Clinical Research 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.

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.

Originally posted on Himalayas