Director of Medical Monitoring & Clinical Science - Work From Home

HCA, Hospital Corporation of America in Nashville, TN 37230 USA

Sarah Cannon, the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom. From discovery to recovery, Sarah Cannon provides patients access to world-class cancer care and boasts world-class physicians, nurses, navigators, the latest technology, screening programs, access to innovative research and clinical trials, personalized medicine and a robust network of cancer experts. 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. Our research arm, Sarah Cannon Research Institute (SCRI), formed 25 years ago is 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 and has been a clinical trial leader in nearly 80 percent of approved cancer therapies in the last 10 years. Summary of Key Responsibilities: This position will provide medical expertise and direction in global clinical drug development strategy and planning, and in the design, conduct, analysis and reporting of clinical trials managed by Sarah Cannon Development Innovations. Responsibilities including medical input to clinical development plans, protocols, risk management and safety handling plans and other study documentation, evaluation of safety information, data analysis and interpretation, and report writing. / / Duties and Responsibilities: Duties include but are not limited to: Medical Director: Development Innovations * Serve as Medical Monitor/study support on a protocol/program basis, as required * Ensure appropriate medical coverage to cover the medical monitoring safety requirements of ongoing trials during all hours of operation * Provide medical and scientific input to the preparation of clinical development plans, protocols, informed consent forms, case report forms, risk management plans, safety handling plans, clinical study reports, manuscripts, and other study documentations and publications, as required * Provide medical and scientific input in the review of clinical data, patient medical safety data and laboratory values * Provide medical and scientific input in the review of data in preparation for Data Safety Monitoring Board meetings, as required and appropriate * Maintain ongoing assessment of all safety profiles and efficacy data for clinical trials managed by Sarah Cannon Development Innovations * Provide medical supervision and training to project teams and study sites * Provide medical monitor training to physician leadership team * Effectively network and collaborate with Sarah Cannon physician leadership and with Sarah Cannon to ensure relevant input to Development Innovations strategic direction and project/program strategies * Respond to Inclusion/Exclusion criteria questions from clinical sites, review violations and track trends, implementing appropriate preventative and/or corrective actions as necessary * Respond to audit report findings in a timely manner * Review study-specific adverse events and safety lab results to identify safety trends * Serve as medical expert in interactions with regulatory authorities and/or Institutional Review Boards/Independent Ethics Committees * Attend conferences, Dose Escalation Meetings, Safety Review Meetings, Data Safety Monitoring Board Meetings, Investigator Meetings, Kick-Off Meetings and Site Initiation Visits, as required * Provide medical and scientific support to RFP proposals to assist in the identification and selection of scientifically robust, practical and fiscally responsible trials and projects, as required * Assist in overseeing quality performance indicators to ensure all research processes work in harmony to accomplish Innovations objectives and goals * Utilize expertise, including knowledge of project and therapeutic advances as well as marketplace developments to participate in internal and external meetings related to review of relevant therapeutic/clinical literature * Maintain thorough and up-to-date working knowledge of GCPs and regulatory requirements relating to clinical development and safety compliance to ethical, legal, regulatory and industry standards * Mentor members of the Innovations team to ensure successful and strategic execution of Innovations projects * Support Innovations Leadership Team in development and execution of strategic growth plan * Maintain clinical/therapeutic acumen in clinical research through education, programs, lectures and publications * Lead the medical monitoring and clinical science teams 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: Broad and in-depth knowledge and cross-functional understanding of drug development and clinical trial methodology; ability to think strategically in relation to clinical development strategy Skills: * Organizational and time management skills * Presentation skills * Computer skills (Word, Excel, Access) Abilities: * Effective communicator, with well developed interpersonal skills * Networking abilities and an ability/willingness to work with individuals across the globe * Ability to inspire, to lead by example and motivate teams to seek solutions and get results * Ability to handle multiple competing priorities effectively Minimum Qualifications Education: Minimum Required: Doctorate Degree Certification or License: Prefer MD or DO degree Experience: Minimum Required: * Clinical research or industry experience (5 yrs) * Track record of successful oversight of large scale, international, multi-center clinical studies * Pharma/CRO management experience **Job:** **Directors & Managers* **Title:** *Director of Medical Monitoring & Clinical Science - Work From Home* **Location:** *Tennessee-Nashville-Sarah Cannon Clinical Operations* **Requisition ID:** *25319-4975*