Sanford Health Manager, Clinical Research | Clinical Research Specialty Area in Fargo, North Dakota
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Facility: Broadway Hospital
Location: Fargo, ND
Job Schedule: Full time
Weekly Hours: 40.00
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. 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. 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. Possess the ability to work collaboratively with a research group or team.
Occasional local travel between sites may be required.
Hours: Monday - Friday, 8a-5p
Bachelor's degree in nursing, biology, psychology, microbiology or related field required. Master's degree preferred.
Dependent on research facilities/laboratories, leadership may independently require employees to have a bachelor’s in nursing and have been a graduate from a nationally accredited nursing program preferred, including, but not limited to, Commission on Collegiate Nursing Education (CCNE), Accreditation Commission for Education in Nursing (ACEN), and National League for Nursing Commission for Nursing Education Accreditation (NLN CNEA).
Minimum of five years of clinical or clinical research experience required. Two years management/leadership experience preferred.
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.
If research facility/laboratory requires a nursing license, must hold an unencumbered RN license with the State Board of Nursing where the practice of nursing is occurring and/or possess multistate licensure if in a Nurse Licensure Compact (NLC) state.
Additionally, may be required to hold a current valid Category II driver’s license
Sanford is an EEO/AA Employer M/F/Disability/Vet.
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Job Function: Research
Req Number: R-16564