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Clinical Team Lead WFH

Nashville, TN

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Clinical Team Lead-WFH
Sarah Cannon, the Cancer Institute of HCA Healthcare, offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom. Sarah Cannon’s cancer programs include individualized patient navigation provided by oncology-trained nurses, more than 1,000 stem cell transplants performed annually throughout the Sarah Cannon Blood Cancer Network, hundreds of clinical trials, and molecular profiling capabilities. Through its services, Sarah Cannon is providing state-of-the-art cancer care close to home for hundreds of thousands of patients, a number unmatched by any single cancer center.
By bringing together a network of globally-recognized cancer experts, we are collaborating and sharing best practices that address every aspect of the cancer journey, from screening and diagnosis through treatment and survivorship.
Sarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 260 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years.
Summary of Key Responsibilities:
The Clinical Team Lead (CTL) is a member of the Project Team and has overall responsibility and accountability for the execution of site management and clinical operations strategy on a regional or global level, as assigned. The CTL will work closely with the Project Manager to facilitate collaboration between Sarah Cannon Development Innovations project teams, research sites and clinical trial sponsors to advance common interests and achieve mutual goals. Ensure that all clinical tasks meet client and Sarah Cannon expectations and are completed in accordance with the contract, protocol, ICH-GCP guidelines and applicable Standard Operating Procedures (SOPs). Provide leadership and expertise to ensure successful execution of site selection, study operations, and management of clinical deliverables.
The CTL will oversee investigator-initiated trials from implementation to completion with a key focus on managing project timelines for clinical deliverables, oversight of investigative sites, and working with cross-functional teams on data collection and site management. Additionally, a CTL may be assigned a sponsor trial depending on the scope, complexity and level of responsibility.
The CTL will follow standard operating procedures, ICH-GCP, and all applicable regulatory requirements
Duties and Responsibilities
Duties include but are not limited to: * Oversee planning and tracking of all assigned clinical activity from study start to completion * Oversee investigative site recruitment/feasibility, essential document collection and review * Create and maintain clinical deliverables and plans * Train site staff to conduct study * Set-up clinical trial monitoring systems and study tools * Review and track enrollment and data entry timelines for sites * Work directly with data management and In-house Clinical Research Associate to monitor site accrual and data retrieval * Identify and assist In-house Clinical Research Associate with resolution of site specific issues * Provide regular site specific clinical status information to team members and project management * Co-monitor, as needed * Conduct team meetings as required * Ensure TMF is set-up and maintained from study start to completion, perform regular audits of TMF documents * Contract and provide vendor management * Develop project status reports and communicate with all applicable team members in and outside the organization * Attend project meetings, conference calls and monthly staff meetings as required * Initiate improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects * May oversee and coordinate the implementation of projects; developing timelines and quality guidelines, coordinate team efforts on trial meeting deadlines and trial milestones depending on trial complexity or stage * Create a variety of reports, documents, training tools, and correspondence as needed to assist participating trial sites and for internal purposes in the ongoing monitoring and evaluation of the projects progress * Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management * Travel may be required. May also involve travel to meetings or attendance at conferences. Overnight stays may also be required. In addition, weekend and evening sessions may be required depending upon the workload and nature of current programs * Duties may include travel to client locations, study sites, and the corporate office * Adhere to professional standards and SOPs established for clinical research
Mandatory: * Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement” * During your employment with Sarah Cannon you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
Knowledge: A body of information needed to perform tasks; May be obtained through education, training or experience * Knowledge of FDA guidelines and GCP is required * Strong understanding of clinical trials, study design, ICH/GCP knowledge and training
Skills: The proficiency to perform a certain task * Excellent professional writing and communication skills * Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, proficient in Microsoft Office software, including Word and Excel, and ability to learn new software if required
Abilities: An underlying, enduring trait useful for performing duties * Excellent organizational and prioritizing capabilities * Resourceful with heightened analytical abilities and problem solving skills in a fast paced environment * Excellent interpersonal skills, detailed-oriented and meticulous
Minimum Qualifications
Minimum Required:
Associate’s Degree (2 year program)
Bachelor’s Degree (4 year program)
Minimum Required:
* 2 years of experience in clinical research as a CRA, study coordinator, or similar research/healthcare profession * Experience in writing technical documents * Experience in clinical trial coordination
* 3 years of experience in clinical research as a CRA, study coordinator, or similar research/healthcare profession * Experience in writing technical documents * Experience in clinical trial coordination
If interested in advancing your career with a growing leader in cancer research please apply today!*
*Supervisors Team Leaders & Coordinators
Clinical Team Lead WFH
Tennessee-Nashville-Sarah Cannon Clinical Operations
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