Responsible for the day-to-day project coordination, oversight and evaluation for research projects, and the associated billing, compliance and budget management for the projects. Create Medicare Coverage Analysis (MCA) for all studies that involve human subject research. Create internal budgets and budget analysis for multiple studies. Monitor attendance, work schedules and assign daily work activities. Ensure the completion of study activities in compliance with protocol, and that study staff acquires appropriate training and certification. Comply with all regulatory and safety requirements and monitor staff in regards to compliance. Provide quality assurance checks for externally completed MCA, internal budgets and budget analysis to review for accuracy and compliance. Assist Research IT with completion of patient study calendar builds in Velos. Present approved MCA to compliance team for review and approval. Must be able to create and document workflows to assist in billing compliance. Maintain and update important contact list of key stakeholders related to billing. Research and apply current trends and updates on clinical trial billing, participate in billing workgroups, attend webinars and provide education and updates to the internal team. Conduct billing audits and support other internal or external auditors, investigate and resolve compliance issues related to the healthcare environment and clinical trial billing. Evaluate regulatory agency reports and formulate responses and corrective actions. Maintain logs, indexes, files, computer databases and other records pertaining to clinical trial billing compliance and risk. Confer with management staff regarding clinical trial billing compliance risk areas and final reports. Provide assistance to other study sites, input and manage evaluation activities, including providing guidance on evaluation questions and outcome measurements. Must acquire in-depth knowledge of study protocols and standard operating procedures. Create policies and procedures and design site specific tools to enhance efficiency and accuracy in completing study tasks. Serve as the lead for new project startups at their local sites. Responsible for submission and maintenance of regulatory documentation. Work closely with others to communicate study needs and concerns in a timely manner. Serve as the liaison with community partners to communicate program objectives, encourage recruitment and ensure compliance with study protocol. Must possess the ability to work collaboratively with a research group or team. Occasional local travel between sites may be required.
Applies an assigned technique for critical thinking in a decision-making process. Maintains sense of commitment to success, personal achievement and satisfaction. Proceeds without seeking unnecessary permission. Plans, conducts, and documents screening interviews. Confidently takes appropriate disciplinary action when necessary. Analyzes budgets for patterns and causes of budgeting inaccuracies. Applies organization's operating principles and practices within own business unit. Establishes positive working relationships with associates from various backgrounds. Communicates well downward, upward, and outward. Applies an assigned technique for critical thinking in a decision-making process. Maintains sense of commitment to success, personal achievement and satisfaction. Proceeds without seeking unnecessary permission.
Certification through Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) required. Certification must be obtained within three years from hire date. May be required to hold a current valid Category II drivers license. Bachelor's degree in biology, phycology, microbiology or related field with at least five years of clinical or clinical research experience or six to eight years of relevant work experience required.
Internal Number: REQ23911
About Sanford Health
At Sanford Health, we are dedicated to the work of health and healing. Every day, we show that commitment by delivering the highest quality of care to the communities we serve. We are leaders in health care and strive to provide patients across the region with convenient access to expert medical care, leading-edge technologies and world-class facilities. In addition to strong clinical care, we are also committed to research, education and community growth. We engage in medical research to not only discover innovative ways to provide care, but also cures for common diseases. We continuously seek new ways to achieve our vision of improving the human condition here in your community, across the region and around the world. The entire team at Sanford Health recognizes the value of healthy families and communities. We continue to gain momentum and expand our reach. Together, we can make a positive difference now, and in the future. Sanford is an EEO/AA Employer M/F/Disability/Vet. If you are an individual with a disability and would like to request an accommodation for help with your online application, please call 1-877-243-1372 or send an email to email@example.com .