Field CRA III (Field Clinical Research Associate III )

Penumbra

2d • $113,000 - $140,000 • Remote

About The Position

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

Requirements

• 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 medical devices/pharmaceutical industry required, and 2+ years of clinical monitoring experience required or equivalent combination of education and experience.
• Strong knowledge of medical terminology required.
• Excellent verbal, written, and interpersonal communication skills.
• Strong organizational and problem-solving skills with 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 with multiple projects.
• Ability to provide guidance and mentoring to junior Clinical staff.

Nice To Haves

• Strong knowledge of laws, regulations, standards and guidance governing the conduct of clinical studies preferred.

Responsibilities

• Serve as the site manager, ensuring data entry and query resolution within a timely manner, as well as ensure the overall high-quality data is reported and audit readiness at the clinical site.
• Participates in the monitoring functions in a clinical study including site management, qualification, initiation, routine monitoring, and final close out visits.
• Monitors, onsite and remotely, ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting.
• Prepares and participates in presentation of protocols and other study conduct requirements at study initiation visits, including training at investigational sites when needed.
• Manages device accountability, inventory, and distribution, with some oversight responsibilities of device complaint/malfunction processing and tracking.
• Manages distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Penumbra trial master file, and for audit readiness.
• Conducts site visits as necessary. Acting as a company liaison, works with clinical sites to resolve any site related issues quickly and effectively.
• Assists Clinical team with the development, approval, and distribution of study-related documents including Case Report Forms (CRF’s), study protocols, study manuals, and other study tools to investigational sites and review committees.
• Drafts informed consents with minimal supervision from Clinical Management.
• Provides mentoring to junior staff regarding protocols, site management/monitoring, etc.
• Participates in maintaining project timeline and preparing routine operations reports.
• Collaborates in the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing of SOP’s 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 the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Benefits

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior