Field CRA III (Field Clinical Research Associate III )

About the Role

The Field Clinical Research Associate III participates in designing and executing clinical studies sponsored by Penumbra to assess the safety and effectiveness of products. This position involves handling confidential patient and company data and interfacing with various internal and external stakeholders. This opportunity is open to qualified applicants across the U.S. Regretfully, sponsorship is not available for this position.

Responsibilities

• Serve as the site manager, ensuring data entry and query resolution in a timely manner, as well as maintaining high-quality data reporting and audit readiness at the clinical site.
• Participate in the monitoring functions of a clinical study, including site management, qualification, initiation, routine monitoring, and final close-out visits.
• Monitor, both onsite and remotely, ongoing compliance with study protocols and site adherence to global regulatory guidelines, including safety reporting.
• Prepare and participate in presentations of protocols and other study conduct requirements at study initiation visits, including training at investigational sites when needed.
• Manage device accountability, inventory, and distribution, with oversight responsibilities for device complaint/malfunction processing and tracking.
• Manage the distribution, collection, and tracking of regulatory documentation to ensure compliance at both the sites and Penumbra trial master file, and for audit readiness.
• Conduct site visits as necessary. Act as a company liaison, working with clinical sites to resolve any site-related issues quickly and effectively.
• Assist the Clinical team with the development, approval, and distribution of study-related documents, including Case Report Forms (CRFs), study protocols, study manuals, and other study tools to investigational sites and review committees.
• Draft informed consents with minimal supervision from Clinical Management.
• Provide mentoring to junior staff regarding protocols, site management/monitoring, etc.
• Participate in maintaining the project timeline and preparing routine operations reports.
• Collaborate in the development and/or maintenance of Clinical infrastructure, such as drafting or reviewing SOPs and Work Instructions.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy, and compliance principles and adhere to applicable regulations, standards, and procedures.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Qualifications

Minimum education and experience: Bachelor’s degree required, with a major in Biological sciences or a health-related field (e.g., Biology, Chemistry, Biochemistry, Nursing, Biomedical or Veterinary Sciences) with 5+ years of experience in clinical/scientific research, nursing, or the medical devices/pharmaceutical industry, and 2+ years of clinical monitoring experience required, or an equivalent combination of education and experience.

Additional qualifications:

• Strong knowledge of medical terminology required.
• Strong knowledge of laws, regulations, standards, and guidance governing the conduct of clinical studies preferred.
• Excellent verbal, written, and interpersonal communication skills.
• Strong organizational and problem-solving skills with the ability to prioritize assignments while handling various projects simultaneously; keen attention to detail.
• Advanced level of competence in Word, Excel, PowerPoint, or equivalent programs.
• Ability to work on teams and manage multiple projects.
• Ability to provide guidance and mentoring to junior Clinical staff.

Working Conditions

• General office, laboratory, and hospital environments.
• Approximately 40-60% travel to research laboratories or hospitals, conferences, and/or other Penumbra-affiliated facilities.
• Potential exposure to blood-borne pathogens and other potentially infectious materials.
• The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer for extended periods.
• Specific vision abilities required include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

Pay

Annual Base Salary Range: $113,000 - $140,000. This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in the pay range. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• Medical, dental, vision, life, AD&D, short- and long-term disability insurance.
• 401(k) with employer match.
• Paid parental leave.
• Eleven paid company holidays per year.
• A minimum of fifteen days of accrued vacation per year, which increases with tenure.
• Paid sick time in compliance with applicable law(s).