Title: Clinical Research Specialist
Location: Mounds View, MN
Duration: 24 Months Possible Extension

HM’s Top Needs:
1. Site Management experience (site or sponsor)
2. Knowledge of/experience with CTSM/EDC/TMF
3. Experience with Good Clinical Practice (GCP)
4. Something nice to have, but not necessary: Experience with Diabetes

Must Have:

• Experience with CTMS and patient data and site management systems (i.e. Veeva Vault, RAD Rave, Oracle)
• Experience with Microsoft Office Applications

Job Description:

Education Required: Bachelor Degree (prefer degree in life sciences or medical/scientific field
Years Experience Required: Minimum 2 years with Bachelor s degree and 0 years experience with advanced degree

Responsibilities

• 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 a commercial potential.
• Oversees and interpret 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 STREAM:

• Typically 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 and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS Autonomy:

• 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 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 effectiveness of 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, Product input, and support decision making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience:

• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
• Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.