Field CRA III (Field Clinical Research Associate III )

About the role

This role is central to ensuring the success of clinical investigations for Penumbra's innovative medical devices. You will be a key player in managing clinical sites and upholding the integrity of study data. Your contributions will directly impact the evaluation of product safety and efficacy.

Key facts

What you'll do

• Oversee clinical trial sites, ensuring timely data entry and query resolution to maintain high-quality, audit-ready information.
• Conduct site management activities, including qualification, initiation, routine monitoring, and close-out visits.
• Monitor adherence to study protocols and global regulatory standards, both on-site and remotely, including safety reporting.
• Prepare and deliver presentations for study initiation meetings, providing necessary training to investigational sites.
• Manage the inventory, distribution, and tracking of study devices, including processing complaints or malfunctions.
• Ensure the collection and proper filing of regulatory documentation for site and company compliance.
• Act as a primary liaison with clinical sites to address and resolve any site-related issues efficiently.
• Support the clinical team in developing and distributing study documents such as Case Report Forms, protocols, and manuals.
• Draft informed consent forms with minimal supervision.
• Provide guidance and mentorship to less experienced clinical staff.
• Contribute to maintaining project timelines and preparing operational reports.
• Assist in developing and maintaining clinical infrastructure, including standard operating procedures and work instructions.
• Uphold the company's Quality Management System and relevant domestic and international regulations.
• Ensure compliance with security, privacy, and applicable regulations.

Requirements

• Bachelor's degree in Biological Sciences or a health-related field (e.g., Biology, Chemistry, Biochemistry, Nursing, Biomedical or Veterinary Sciences).
• A minimum of 5 years of experience in clinical research, nursing, or the medical device/pharmaceutical industry.
• At least 2 years of direct clinical monitoring experience.
• Strong understanding of medical terminology.
• Proficiency in Microsoft Word, Excel, and PowerPoint, or equivalent software.
• Excellent verbal, written, and interpersonal communication abilities.
• Strong organizational and problem-solving skills with the capacity to manage multiple projects simultaneously and prioritize tasks.
• A keen eye for detail.

Nice to have

• Familiarity with laws, regulations, standards, and guidance governing clinical study conduct.

Skills & tools

• Clinical Trial Management
• Site Monitoring
• Data Management
• Regulatory Compliance
• Microsoft Office Suite (Word, Excel, PowerPoint)

Practical notes

• This position requires approximately 40-60% travel to research laboratories, hospitals, conferences, and other Penumbra facilities.
• The role involves working in general office, laboratory, and hospital environments, with potential exposure to infectious materials.
• Employees will be required to stand, walk, sit, and use a computer for extended periods, with specific vision abilities needed for reading and detailed observation.
• A comprehensive benefits package is offered, including medical, dental, vision, life insurance, 401(k) with employer match, paid parental leave, holidays, and accrued vacation and sick time.