Clinical Research Regulatory Specialist

Benefits

Qualifications

• •Proven written and oral communication skills
• •Proven leadership skills in project management, including project management tools and techniques
• •Exceptional computer skills, including Microsoft Office, Excel and PowerPoint
• •Ability to manage time reactive projects in order to meet deadlines
• •Excellent ability to establish and maintain effective working relationships
• •EDUCATION - Associate's or 2 years of work experience above the minimum qualification
• •EXPERIENCE - 3 Years of Experience
• •4 more items(s)

Responsibilities

• •The Clinical Research Regulatory Specialist supports clinical research by developing protocol-specific documents and reports
• •This role focuses on developing, submitting, maintaining, filing, and reporting regulatory documents
• •The goal is to comply with all internal, external, and federal policies and regulations for research involving human subjects
• •This position also offers regulatory guidance to internal clinical research programs to ensure compliance with all relevant policies, procedures, and regulations
• •Prepares, facilitates, and coordinates the process for accurate and timely IRB application submissions
• •This includes protocol revisions or amendments for new treatments, administrative changes, subject population changes, funding, recruitment, site changes, informed consent changes, or dual enrollment
• •These are for IRB-approved protocols as required by federal regulations and internal policy
• •Ensure all documents are complete and meet the IRB's requirements before submission
• •Follow up, communicate, and facilitate responses to queries from the IRB, Sponsor, and other committees after their review
• •Coordinates the preparation and submission of consent forms
• •Ensures compliance with federal, state, and local biomedical research regulations
• •Obtains Sponsor approval of consent forms before submitting to the IRB
• •Facilitates and coordinates the timely submission of regulatory documents and IRB submissions
• •Partners with research nurses, clinical research coordinators, and investigators to prepare regulatory documents
• •Ensures that regulatory binders are audited and maintained
• •Tracks workload and status of pending protocols and related documents
• •This ensures efficient customer service for the Research team
• •Participates in quality assurance (QA) and control programs for projects and patient data, as needed
• •Oversees QA initiatives for the department
• •Helps research staff and managers during sponsor and FDA audits
• •Facilitates investigator-initiated research by ensuring all regulatory requirements are met
• •This includes ensuring trial registration, results, and reporting are completed on time, consistent with federal regulations
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