HCA, Hospital Corporation of America Regulatory Affairs Specialist in Nashville, Tennessee
Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute’s Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.
Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.
Sarah Cannon Development Innovations works with Sarah Cannon Research Institute strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute network. This reach allows Sarah Cannon Development Innovations to offer sponsors access to a diverse and varied patient population, spanning multiple tumor types and disease stages. These relationships further enhance the depth and breadth of Sarah Cannon Development Innovations’ therapeutic expertise, enabling it to provide focused, strategic operational support. This support ensures that clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.
Summary of Key Responsibilities: Primary responsibilities include planning and managing regulatory affairs compliance for assigned clinical trials. This position will work closely with the project teams to ensure compliance while meeting strict deadlines.
Duties and Responsibilities: Duties include but are not limited to: * Prepare Central IRB and/or ethics committee submissions (protocol, amendments, consents, investigator brochures, safety updates) for assigned studies * Review essential trial documents to ensure accuracy, completeness, and compliance with ICH/GCP guidelines, local SOPs, and sponsor requirements * Determine site regulatory readiness for site activation * Assist in ClinicalTrials.Gov trial registration, updates and ongoing maintenance of trial status, as applicable * Query sites for correction and/or revision of regulatory documents or request sites submit missing documents * Review informed consent form templates and any changes made by investigative sites to ensure compliance with CFR, GCP, HIPAA, and study-specific requirements * Assist project teams in maintaining accurate and current essential documents * Distribute safety updates for assigned studies * Support teams by serving as subject matter expert regarding essential documents, GCP, and regulatory policy * Assist project teams with preparation for and participation in internal and external audits * Apprise Department Manager and other leadership, as appropriate, of all study and site-specific regulatory issues for guidance and follow through * Archive study specific regulatory documentation and correspondence * Contribute to team decision-making concerning departmental policies, regulatory requirements, strategies and SOPs * Attend project team meetings and staff meetings as appropriate * Participate in educational activities and programs * Maintain strictest confidentiality *Mandatory: * * Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement” * During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
Competencies: * Knowledge:/A body of information needed to perform tasks; May be obtained through education, training or experience/ o Working knowledge of regulatory, medical, and clinical research terminology o Knowledge of IRB, FDA and GCP guidelines required * Skills:/The proficiency to perform a certain task / o Computer skills, specifically with MS Office products including Outlook, Word, and Excel * Abilities:/An underlying, enduring trait useful for performing duties / o Ability to multi task and meet strict deadlines o Exceptional level of attention to details in a fast paced environment o Interpersonal, communication, and organizational skills
Education: Minimum Required: Associates Degree (2 yr program) Preferred: Bachelor's College Degree (4 yr program)
Experience: * Experience in healthcare, research, science or other professional field, one of which is in clinical research or regulatory affairs (2 yrs) * A degree specific to regulatory affairs or clinical research may be substituted for one year experience in clinical research or regulatory affairs
Job: *Quality Risk & Safety
Title: Regulatory Affairs Specialist
Location: Tennessee-Nashville-Sarah Cannon Clinical Operations
Requisition ID: 25319-5437