Clinical Research Spec - Exempt

Join our team in Mounds View, MN, a vibrant community offering a great balance of work and lifestyle. We are seeking a dedicated professional to oversee, design, and develop clinical evaluation research studies, ensuring they meet medical needs and commercial potential. This role requires a combination of technical expertise and project management skills to drive clinical studies from conception through implementation.

Must Have:

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

Top Needs:

• Site Management experience (site or sponsor)
• Knowledge of/experience with CTSM/EDC/TMF
• Experience with Good Clinical Practice (GCP)
• Nice to have: Experience with Diabetes

Education and Experience Required:

• Bachelor's Degree (preferably in life sciences or medical/scientific field)
• Minimum 2 years of relevant experience with a Bachelor's degree or 0 years with an advanced degree

Work Schedule:

Full-time, 40 hours a week on-site as per the mandate.

Responsibilities:

• Prepare and author protocols and patient record forms.
• Conduct registered and nonregistered clinical studies of products.
• Oversee and interpret results of clinical investigations for new drug device or consumer applications.
• Resolve operational aspects of clinical trials in conjunction with project teams.
• Ensure compliance with SOP, GCP, and specific country regulations.
• May prepare clinical trial budgets and be responsible for clinical supply operations, site, and vendor selection.

Specialist Career Stream:

This role is for an individual contributor with responsibility in a professional discipline or specialty. You will deliver and manage projects assigned, working with other stakeholders to achieve desired results. You may also act as a mentor to colleagues or direct the work of other lower-level professionals.

Differentiating Factors:

• Autonomy: Work independently with general supervision on larger, moderately complex projects/assignments.
• Organizational Impact: Set objectives for your own job area to meet project and assignment objectives.
• Innovation and Complexity: Address general problems and issues, making adjustments or recommending enhancements to improve effectiveness.
• Communication and Influence: Communicate primarily with internal contacts to share information, gain input, and support decision-making.
• Leadership and Talent Management: May provide guidance and assistance to entry-level professionals.