Clinical Research Spec - Exempt

Join our dynamic team in Mounds View, MN, where innovation meets excellence in clinical research. We are seeking a highly motivated individual to oversee, design, and develop clinical evaluation research studies. This role offers the opportunity to work full-time on-site in a collaborative and cutting-edge environment.

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 3 Candidate Experience Requirements

• Site management experience (site or sponsor)
• Knowledge/experience with CTMS/EDC/TMF
• Experience with Good Clinical Practice (GCP)

Education and Experience

• Education Required: Bachelor's Degree (preferably in engineering, life sciences, or related medical/scientific field)
• Years of Experience Required: Minimum 2 years of experience

Responsibilities

Responsibilities may include the following and other duties may be assigned:

• 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 a medical need and/or offer commercial potential.
• Oversee and interpret results of clinical investigations in preparation for new drug device or consumer applications.
• Oversee and resolve 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.
• May prepare clinical trial budgets and be responsible for clinical supply operations, site, and vendor selection.

Career Stream

This position typically involves responsibilities in a professional discipline or specialty. The role requires delivering and/or managing projects assigned and collaborating with other stakeholders to achieve desired results. You may act as a mentor to colleagues or direct the work of other lower-level professionals.

Required Knowledge and Experience

The position requires practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience. A University Degree and a minimum of 2 years of relevant experience are required, or an advanced degree with 0 years of experience.