Field CRA III (Field Clinical Research Associate III )

About the role

This position is essential to the successful execution of clinical investigations for Penumbra's innovative medical devices. As a Field CRA III, you will be responsible for managing clinical sites, ensuring adherence to study protocols, and maintaining the integrity of data collected during trials. Your role will involve close collaboration with investigative sites, monitoring compliance with regulatory standards, and supporting the overall clinical development process. Your contributions will directly impact the evaluation of product safety and efficacy, helping to bring new medical solutions to market. This role requires a proactive approach to site management, data quality assurance, and regulatory compliance, with a focus on delivering accurate, timely, and high-quality clinical data.

Key facts

What you'll do

• Oversee clinical trial sites to ensure that study activities are conducted according to protocol, regulatory requirements, and company standards.
• Conduct site qualification, initiation, routine monitoring, and close-out visits, either remotely or on-site, to verify compliance and data accuracy.
• Monitor adherence to study protocols and global regulatory standards, including safety reporting, adverse event documentation, and compliance with Good Clinical Practice (GCP).
• Prepare and deliver presentations for study initiation meetings, providing training and guidance to investigative site staff on study procedures, documentation, and compliance.
• Manage the inventory, distribution, and tracking of study devices, ensuring proper handling, storage, and documentation.
• Process and document complaints, malfunctions, or adverse events related to study devices, ensuring timely reporting and resolution.
• Collect, review, and organize regulatory documentation such as IRB approvals, informed consent forms, and site initiation packets to ensure regulatory compliance.
• Act as the primary liaison with clinical sites, addressing and resolving issues related to study conduct, data collection, or regulatory compliance efficiently and professionally.
• Support the development, review, and distribution of study-related documents including Case Report Forms (CRFs), protocols, manuals, and training materials.
• Draft and review informed consent forms with minimal supervision, ensuring clarity and compliance with applicable regulations.
• Provide mentorship and guidance to less experienced clinical staff, fostering a collaborative and compliant study environment.
• Assist in maintaining project timelines, tracking study milestones, and preparing operational reports for internal and external stakeholders.
• Contribute to the development and maintenance of clinical infrastructure, including standard operating procedures (SOPs), work instructions, and quality management systems.
• Uphold the company's Quality Management System and ensure all activities comply with domestic and international regulations governing clinical research.
• Maintain security, privacy, and confidentiality standards in accordance with applicable laws and company policies.
• Support continuous improvement initiatives to optimize clinical monitoring processes and site management practices.
• Participate in team meetings, training sessions, and audits to ensure ongoing compliance and professional development.

Requirements

• Bachelor's degree in Biological Sciences, Nursing, Biomedical Sciences, Veterinary Sciences, Chemistry, Biochemistry, or a related health field.
• 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, preferably with medical devices or pharmaceutical trials.
• Strong understanding of medical terminology, clinical trial processes, and regulatory requirements.
• Proficiency in Microsoft Word, Excel, and PowerPoint, or equivalent software, with the ability to create reports and presentations.
• Excellent verbal and written communication skills, with the ability to interact effectively with clinical site staff and internal teams.
• Strong organizational skills, with the ability to manage multiple projects simultaneously and prioritize tasks effectively.
• Attention to detail and a high level of accuracy in data review and documentation.
• Ability to work independently, demonstrate initiative, and adapt to changing priorities.
• Valid driver's license and willingness to travel approximately 40-60% of the time to research laboratories, hospitals, conferences, and Penumbra facilities.
• Knowledge of Good Clinical Practice (GCP), ICH guidelines, and relevant international and domestic regulations.

Nice to have

• Familiarity with laws, regulations, standards, and guidance governing clinical study conduct, including FDA, EMA, or other regulatory bodies.
• Experience working with clinical trial management systems (CTMS) or electronic data capture (EDC) platforms.
• Prior exposure to the medical device industry, especially in monitoring or site management roles.
• Knowledge of risk management and safety reporting procedures in clinical trials.
• Ability to review and interpret clinical data and documentation critically.

Skills & tools

• Clinical Trial Management
• Site Monitoring and Management
• Data Management and Review
• Regulatory Compliance and Documentation
• Microsoft Office Suite (Word, Excel, PowerPoint)
• Electronic Data Capture (EDC) systems (if applicable)
• Good Clinical Practice (GCP) standards
• Risk assessment and safety reporting procedures

Practical notes

• This position requires approximately 40-60% travel to research laboratories, hospitals, conferences, and Penumbra facilities across the United States.
• The work environment includes offices, laboratories, and hospital settings, with potential exposure to infectious materials and other hazards.
• Employees should be prepared to stand, walk, sit, and use a computer for extended periods, with good visual acuity for reading and detailed observation.
• The role involves working in diverse environments, requiring adaptability and adherence to safety protocols.
• A comprehensive benefits package is provided, including medical, dental, vision, life insurance, 401(k) with employer match, paid parental leave, holidays, and accrued vacation and sick time.
• The company emphasizes compliance with security, privacy, and confidentiality standards, ensuring all activities meet applicable regulations.
• Ongoing training and professional development opportunities are available to support career growth within the company.