Clinical Research Specialist — Site & Data Management

Planet Pharma; Coon Rapids (MN); On-site; USD 60,000 - 80,000; Full time

Job summary

Planet Pharma is seeking a Clinical Research Associate to support planning and execution of clinical studies, including site management, study documentation, data review, and coordination with internal and external stakeholders. This role reports to a Clinical Study Manager and ensures adherence to SOPs, GCP, and regulatory requirements.

Responsibilities may include start-up/closeout activities, maintaining clinical systems and documentation, and liaising with sites and vendors within the region.

Qualifications

• Bachelor's degree required.
• 1-2 years of relevant clinical research experience.
• Willing to work 40 hours per week.

Responsibilities

• Oversee, design, plan and develop clinical evaluation research studies.
• Prepare and author protocols and patient record forms.
• Conduct registered and non-registered clinical studies of products with medical need or commercial potential.
• Oversee and interpret results of clinical investigations for new drug, device or consumer applications.
• Manage operational aspects of clinical trials with project teams and SOPs, GCP and country regulations.
• May manage clinical supply operations, site and vendor selection.
• Represent the company in clinical research activities within the region and engage with local customers and authorities.
• Build and maintain relationships with internal and external stakeholders and drive local evidence dissemination.

Education

Bachelor's degree

Tools

CTMS

EDC

TMF

Job description

Planet Pharma is seeking a Clinical Research Associate to support planning and execution of clinical studies, including site management, study documentation, data review, and coordination with internal and external stakeholders. This role reports to a Clinical Study Manager and ensures adherence to SOPs, GCP, and regulatory requirements.

Responsibilities may include start-up/closeout activities, maintaining clinical systems and documentation, and liaising with sites and vendors within the region.