Sr Clinical Research Spec - Exempt

Join our dynamic team in Minneapolis, MN, a vibrant city known for its thriving medical and research community. This role offers a unique opportunity to contribute to innovative clinical research projects within the medical device industry.

Key Responsibilities

• Oversee, design, plan, and develop clinical evaluation research studies.
• Prepare and author protocols and patient record forms.
• Conduct registered and nonregistered clinical studies of products that satisfy medical needs or offer commercial potential.
• Interpret results of clinical investigations in preparation for new drug device or consumer applications.
• Resolve operational aspects of clinical trials in conjunction with project teams, adhering to standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations.
• Prepare clinical trial budgets and manage clinical supply operations, site, and vendor selection.

Specialist Career Stream

• Typically an individual contributor with responsibility in a professional discipline or specialty.
• Deliver and/or manage projects, working with stakeholders to achieve desired results.
• Act as a mentor to colleagues or direct the work of lower-level professionals.

Differentiating Factors

• Autonomy: Work independently under limited supervision to determine and develop approach to solutions. Coach and review the work of lower-level specialists; may manage projects/processes.
• Organizational Impact: Responsible for entire projects or processes within job area. Contribute to work group objectives by building relationships and consensus to reach agreements on assignments.
• Innovation and Complexity: Address complex problems requiring understanding of multiple issues or specialties. Make process, system, or product improvements to enhance job area performance.
• Communication and Influence: Communicate with senior internal and external customers and vendors. Exchange information to achieve objectives and influence decision-making.
• Leadership and Talent Management: Provide guidance, coaching, and training to other employees within the job area. Manage projects by delegating work and reviewing others' work products.

Required Knowledge and Experience

• Advanced knowledge of the job area, typically obtained through advanced education combined with experience.
• Practical knowledge of project management is beneficial.
• Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.

Education and Experience

• Bachelor's degree required.
• 3 or more years of clinical research experience within an industry sponsor, preferably in medical devices.
• Experience with site activation and site management activities.

Work Schedule and Location

• Full-time, ideally 40 hours per week.
• Preferably on-site in the Minnesota office, with alternatives in Colorado and Irvine, but Minnesota is prioritized.
• On-site presence required, with potential for conversion to a full-time employee where in-office attendance will be necessary.