Website LanceSoft Inc
LanceSoft Inc
Company : LanceSoft Inc
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.