HCA, Hospital Corporation of America Lead Regulatory Coordinator in Nashville, Tennessee
Sarah Cannon Research Institute(SCRI) is the research arm of HCA’s global cancer enterprise, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.
__ _Summary of Key Responsibilities:_ Primary responsibilities include leading and training a team of Regulatory personnel. Secondary responsibilities include managing and planning regulatory affairs compliance for sites in networks with a direct focus on support. This position will work closely with the regulatory affairs management, department director and/or primary investigators to ensure compliance, improve regulatory processes, and handle multiple tasks while meeting strict deadlines.
_Duties and Responsibilities:_ Duties include but are not limited to:_ _ * Lead, train and mentor a team of Regulatory Coordinators to provide site level regulatory support * Provide the initial point of escalation for any site level regulatory issue site level regulatory issues * Communicate and escalate unresolved site level issues at the appropriate time to the proper level of management * Keeps regulatory management abreast of issues and progress on all assigned projects and the projects of team members * Provide back-up support and/or regulatory coordinator assistance as needed for team members * Develops performance metrics and regulatory departmental goals in relation to the strategic site support * Provides staff training to enhance the customer service skills and overall regulatory understanding related to required documents * Develops and implements an approved archiving system for study specific regulatory documentation and correspondence * Apprises management of important regulatory issues and obtains guidance when necessary * Provides proactive and creative recommendations on how to meet goals and handle identified deviations *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 Medical and clinical research terminology o MS Office * _Skills:_/The proficiency to perform a certain task / o None specified * _Abilities:_/An underlying, enduring trait useful for performing duties / o Works within deadlines o Requires interpersonal, communication, and organizational skills *_ *_ _ Education:_* Minimum Required: Associate's Degree Preferred: Bachelor Degree
_Experience:_ * Customer focus experience * Direct related regulatory experience
Title: Lead Regulatory Coordinator
Location: Tennessee-Nashville-Sarah Cannon Research Institute Clinical Operations
Requisition ID: 03058-3507