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.

Duties/Responsibilities:

• Performs startup activities including IRB submissions, regulatory documentation, vendor and training access, etc.
• Assists with the management of Rovia’s eRegulatory platform Complion, 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.

Required Skills/Abilities:

• Excellent interpersonal and communication skills.
• Strong understanding of clinical trial methodology and regulatory guidelines required.
• Sound knowledge of medical terminology.
• Sound knowledge of ICH/GCP, Regulatory requirements, FDA and HIPAA policies and practices.
• 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.

Education and Experience:

• High school diploma required, bachelor’s degree preferred.
• 2+ years in clinical research regulatory required.
• Significant experience in study start-up and/or feasibility strongly preferred.
• Strong understanding of clinical trial methodology and regulatory guidelines required.

• Performs startup activities including IRB submissions, regulatory documentation, vendor and training access, etc.
• Assists with the management of Rovia’s eRegulatory platform Complion, 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