Nemours Children's Health is looking for a Clinical Trials Business Specialist (CTBS). The Clinical Trials Business Specialist prepares budget analysis and internal budgets for industry sponsored clinical trials, negotiates budget with sponsor/sponsor representative, and facilitates contract legal review. CTBS Collaborates with PI, Study Staff and departments involved in the study to ensure anticipated study participation costs are covered including research procedures, subject costs, personnel, and administrative fees. CTBS documents and maintains detailed, timely status of all clinical trial budgeting progress and legal review status and ensures all regulatory and legal reviews are complete and approved prior to contract execution.
This is a remote/work from home position.
This is a remote/work from home position.
- Prepare budget analysis and internal budgets for industry sponsored clinical trials, negotiates budget with sponsor/sponsor representative.
- Facilitate contract and grant amendments and/or extensions, as needed, based on protocol or budgetary changes in coordination with the clinical study team.
- Facilitate and complete Medicare/Medicaid Coverage analysis to ensure compliant billing for clinical trials.
- Prepare comprehensive, accurate and transparent budgets (true cost & negotiated) and reporting on forecasted income and expenditures on clinical trials finances.
- Develop and propose Nemours cost sharing budget if applicable for review and approval by Director of the Office of Sponsored Project and Administrator for Research, then escalate as needed.
- Work with clinical trial managers, study team, clinical departments, and research accounting on all clinical trial budgets incorporating costs related to hospital services, pharmacy, data management, IRB, investigator salaries, and quality assurance. Ensure all costs related to the conduct of each trial are captured so that there is no plausible financial risk to the Research and Nemours.
- Work with research administration (Contracts Manager) on clinical trial contracts and budgets with industry sponsors and ensure all issues related to cost reimbursement, payment schedules, deliverables, and publishing and intellectual property rights, are in the best interest of the Nemours and the study investigator.
- Provide interpretation, clarification and procedural guidance to management and peer-colleagues as related to financials and budgets for clinical trials
- Develop protocol specific study status reports (SSR) and payment/billing schedules to include invoicing terms, payment timetables, and protocol calendar. Update information SSR with any amended costs due to contract and protocol amendments.
- Responsible for compliance with all Nemours, federal, state, and other agency financial policies, procedures, and regulations.
- Administrative tasks such as requesting activity numbers and build study status reports.
- Bachelor's degree required
- Experience with Research Administration and Clinical Trials Management and Development
- Experience in an academic or non-academic research healthcare organization, Advanced grants management and post-award experience
- Experience with Microsoft Suite, EPIC Research, Lawson
HeadquartersJacksonville, FL, United States
1001 to 5000
$100M to $500M (USD)
Nemours is committed to improving the health of children. As a non-profit children’s health organization, we consider the health of every child to be a sacred trust. Through family-centered care in our children’s hospitals and clinics in Delaware, New Jersey, Pennsylvania and Florida, as well as world-changing research, education and advocacy, Nemours fulfills the promise of a healthier tomorrow for all children — even those who may never enter our doors. Nemours began more than 70 years ago with the vision of Alfred I. duPont to improve the lives of children and to do whatever it takes to prevent and treat even the most disabling childhood conditions. Today, through our children’s hospitals and health system, we directly care for 250,000 children annually in Delaware Valley and Florida, including families who travel from across the country and world to see our specialists — treating every child as we would our own. We also reach beyond the walls of our hospitals and clinics to be a voice for children on a national and international level, and to lead the way in prevention, intervention, education, and research. Nemours is growing to better serve the children and families in our care. We have 1.1 million square feet of space currently devoted to providing children’s healthcare or under construction, all designed with significant input and advice from our patients and families. Be Part of Our Promise Our team of more than 4,600 dedicated Associates has cared for millions of kids and their families in our world-class pediatric health system of hospitals and specialty clinics located across the Delaware Valley and Florida. As a Nemours Associate, you’ll have the opportunity to collaborate across disciplines, pursue your passion for excellence in children’s health care, and advance professionally as you work alongside some of the country’s top pediatric practitioners. ACCOLADES Setting Higher Standards in Children's Health Care • A leader in children's health for more than 70 years • Two freestanding children's hospitals: world-renowned Nemours Children's Hospital, Delaware in Wilmington, and the new Nemours Children's Hospital, Florida in Orlando. • U.S. News & World Report’s 2013-14 edition of "Best Children's Hospitals" ranked Nemours Children's Hospital, Delaware in 4 out of 10 specialties and was named #14 in the country for orthopedic specialty care. • 152 Nemours physicians are ranked among the Best Doctors in America® for 2011-2012 by Best Doctors®, Inc. • Family-centered care ranked in the top 20% in key satisfaction areas • Nemours Children's Hospital, Delaware nursing program granted Magnet® status in 2012 by the American Nurses Credentialing Center (ANCC), in recognition for its professional nursing excellence Quality & Safety • Nemours Children's Hospital, Delaware was awarded the Elite Distinction as one of 12 Leapfrog Top Children's Hospitals in the country in 2012, recognizing exceptional quality and patient safety • Excellent quality and safety outcomes, including hospital readmissions for asthma, patient survival rates and surgical infection prevention Health Information & Technology • Advanced Electronic Health Record (EHR) technology that works seamlessly across multiple locations • Among the "Most Wired" hospitals and health systems in the U.S., Hospitals and Health Networks magazine, 2012 • HIMSS Davies Organizational Award of Excellence from the Healthcare Information and Management Systems Society (HIMSS) • Nemours Center for Children's Health Media, creator of KidsHealth.org — the #1 most-visited website devoted to children's health
Great place to work and move up in your career. Love the people i work with and work from home permanently. You will love it here…apply and enjoy working from home
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