Clinical Research Associate II

Summary

Join Penumbra as a Clinical Research Associate II IH and contribute to the planning, design, and execution of clinical studies assessing product safety and effectiveness. You will work with confidential information and collaborate with internal and external stakeholders. Key responsibilities include drafting informed consent templates, assisting with study document development and distribution, driving study start-up and closeout activities, and ensuring regulatory compliance. This role requires a Bachelor's degree in a related field and 3+ years of experience in clinical/scientific research. The position offers a competitive compensation package, including a generous benefits package and opportunities for professional growth within a collaborative team environment.

Requirements

Bachelor's degree in Biological Sciences or related field (e.g., Biology, Chemistry, Biochemistry, Nursing, Biomedical or Veterinary Sciences) with 3+ years of experience in clinical/scientific research, nursing or equivalent combination of education and experience

Responsibilities

• Draft study-specific informed consent templates
• Assist management with developing/maintaining project timeline and preparing routine operations reports
• Assist with preparing the meeting materials to be presented at the study team meeting
• Assist with the development, approval, and distribution of study-related documents including Case Report Forms, study manuals, and other study tools to investigational sites and review committees as directed by management
• Drive study start up process across multiple studies inclusive of ICF review, budget negotiation and assist clinical sites with their IRB submission
• Drive study amendment and closeout activities across multiple studies
• Motivate clinical sites to meet study endpoints and achieve milestones
• Provide support to Project Management to establish and implement standard processes around clinical trial management
• Collaborate with the Clinical Field team to identify areas for improvements in the site activation process
• Distribute, collect, and track regulatory documentation to ensure compliance at both the sites and Penumbra central file, and for audit readiness
• Assist with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP’s and Work Instructions. Provide input only
• Provide periodic updates to management regarding site start-up progress. Communicate potential or actual delays and propose actions to ensure that project timelines are met
• Participate in internal and/or external audits
• 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

• Basic knowledge of medical terminology
• Strong computer skills (experience with spreadsheets and word processing programs)
• Familiar with laws, regulations, standards, and guidance governing the conduct of clinical studies
• Strong verbal and written communication skills
• Strong interpersonal and organizational skills
• Detail oriented and good problem-solving ability
• Ability to work on teams and with multiple projects

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)