Clinical Research Regulatory Specialist Bilingual - Doral, FL
1 day ago
Job description
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:
- 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, bachelor's degree preferred.
- 1+ years of clinical research experience with an emphasis in regulatory and QA.
- License/certification status with CEUs, as applicable.
- Current GCP certification.
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