Clinical Research SpecialistResponsibilities may include the following and other duties may be assigned:Oversees, designs, plans, and develops clinical evaluation research studies.Prepares and authors protocols and patient record forms.Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer commercial potential.Oversees and interprets results of clinical investigations in preparation for new drug, device, or consumer application.Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations, and may prepare clinical trial budgets.May be responsible for clinical supply operations, site, and vendor selection.Specialist Career StreamTypically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).Differentiating FactorsAutonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional assignments.Innovation and Complexity: Problems and issues faced are general and may require understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve the effectiveness of the job area.Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues in order to inform, gain input, and support decision-making.Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.Required Knowledge and ExperienceRequires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.LocationThis position is based in Virtual, MN, offering the flexibility of remote work while being part of a dynamic and innovative team. Enjoy the benefits of working from anywhere while contributing to cutting-edge clinical research studies.
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