layiq

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worthy; deserving; fitting; suitable.

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Clinical Trial Support - Regulatory Affairs Administrator at Texas A&M University System | LAYIQ

Master’s degree in education, business, research, science related or legal field.
Any of the following: Certified IRB Professional (CIP), Certified Clinical Research Coordinator or Professional (CCRC/CCRP) Certified Clinical Trials Manager (CTM) Regulatory Affairs Certification (RAC) or Juris Doctorate (J.D.)
Knowledge of biomedical and behavioral research including clinical trials in an institution of higher education.
Experience with FDA commercialization pathways, INDs, IDEs, PMAs, 510(k)s, documentation packages and annual reports.
Ability to provide efficient customer service through the preparation, submission and management and maintenance of regulatory submissions.
Familiarity with funding agency requirements (government, international, private, industry, etc.).
Knowledge of regulations and ethical principles regarding human research including HIPAA, FDA, OHRP and international standards in addition to above knowledge, skill and abilities.
Understanding of both compliance and commercialization timelines
Ability to cultivate and maintain professional working relationships with people of varying backgrounds.
Essential Duties/Tasks
Management and Development of Clinical Trial Support Services and associated Training and Education Program - Develops implements and manages regulatory strategies, processes, resources and communications to ensure all activities comply with federal regulations, institutional policies, and sponsor requirements. Collaborates with investigators and internal or external stakeholders to plan, develop, review and support clinical research through the research life cycle. Assist investigators with drafting and editing clinical research protocols, submission packets and related documents. Ensures all research materials are clear, accurate, consistent and compliant with regulatory standards, scientific objectives and appropriately prepared for regulatory submission. Develops and implements institution-wide training and education plans aimed at enhancing the understanding of regulatory requirements including best practices for conducting clinical research.
Duties may include any of the following - Provides guidance and support to investigators on regulatory requirements and product commercialization pathways. Ensures all documentation and processes follow applicable regulatory standards and best practices. Assists with the preparation and filing/submission of regulatory documents for protocol compliance and/or product approvals as needed. Communicates with regulatory agencies regarding regulatory requirements for investigational drugs, devices or biological products. Tracks and communicates regulatory changes and timelines affecting clinical research and associated products. Maintains audit ready files and documentation for ongoing regulatory compliance. Identifies learning needs within the research community and coordinates, plans, develops, and implements regulatory training activities including seminars, presentations, newsletters, and electronic communications; Assists with maintenance of website by providing up-to-date information, templates and other materials. Provides advanced training to investigators, other offices, and staff. Assists with new staff training and education. Stays abreast of research compliance best practices and all applicable institutional guidelines and federal regulations.
Study Management - Assists with study management, tracking, and reporting from feasibility to close out by maintaining databases and records through various systems (CTMS, RedCap, Maestro, etc.). Works with Digital Health, Core Facilities and study sites to ensure study data, milestones, and timelines are properly updated and aligned with institutional and sponsor requirements. Schedules remote or in-person visits, to assist with post approval monitoring and quality improvement activities. May assist with the supervision, training, and evaluation of the work of other staff and/or student workers.
Feasibility Assessment - Supports the feasibility and intake process by performing early assessment and intake of clinical research; reviews study requirements, operational needs, study population, timelines, resource availability, and regulatory and compliance readiness. Coordinates with investigators, sponsors, research teams, finance, regulatory, ancillary departments, biostatisticians and core facilities to determine whether a study is practical, aligned with institutional capabilities, and appropriate to move forward into start-up.
Why Texas A&M University?

Clinical Trial Support - Regulatory Affairs Administrator

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