Clinical Research Associate II

Summary

Join Penumbra as a Clinical Research Associate II and contribute to the execution of clinical studies assessing the safety and effectiveness of our products. You will work with confidential data, interact with various stakeholders, and manage clinical trial aspects. This role requires a Bachelor's degree in a relevant field and 3+ years of clinical research experience, including 1+ year of clinical monitoring. The position involves site management, data quality assurance, regulatory compliance monitoring, and document preparation. We prioritize candidates in the Midwest or Western US regions. Penumbra offers a competitive compensation package and a comprehensive benefits program.

Requirements

• Bachelor's degree required in biological sciences or health-related field (e.g., biology, chemistry, biochemistry, nursing, biomedical or veterinary sciences) with 3+ years of experience in clinical/scientific research, nursing, or medical devices/ pharmaceutical industry required, and 1+ years of clinical monitoring experience, or an equivalent combination of education and experience
• Working knowledge of medical terminology required
• Intermediate level of competence in Word, Excel, PowerPoint or equivalent programs is required
• Ability to work on teams and with multiple projects

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
• Participate in the monitoring functions in a clinical study including site management, qualification, initiation, routine monitoring, and final closeout
• Monitor, onsite and remotely, ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting, including training at investigational sites when needed
• Prepare and participate in presentation of protocols and other study conduct requirements at study initiations including training at investigational sites when needed
• Manage device accountability, inventory, and distribution, with responsibilities of device complaint/malfunction processing and tracking
• Participate in the distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and trial master file, and for audit readiness
• Conduct site visits, as necessary. Acting as a company liaison, work with clinical sites to resolve any site related issues quickly and effectively
• Assist 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
• Draft informed consents with supervision from line manager
• Assist with the development and/or maintenance of clinical infrastructure such as the drafting or reviewing of SOP’s and work instructions
• Provide mentoring to junior staff regarding protocols, site management/monitoring, etc
• Assist with maintaining project timeline and preparing routine operations reports
• Assist with the development and/or maintenance of clinical infrastructure such as the drafting or reviewing 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

Preferred Qualifications

• Familiarity with 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; keen attention to detail
• Ability to provide guidance and mentoring to junior clinical staff

Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s)