As an experienced member of our clinical research team, you will participate in the planning, designing, and execution of clinical studies to assess the safety and effectiveness of Penumbra’s products. Working with confidential patient and company data, you will interface with internal and external stakeholders, managing and monitoring our clinical trials. Currently we are looking to add to our Team in Alameda, CA. Alternatively, we will consider individuals in the Central or NE Regions.
The job
Provide leadership and guidance to Clinical Research team.Participate in clinical research site management, qualification, initiation, interim monitoring, and study close out.Train and mentor junior team members.Develop and maintain project timelines.Assist with the development, approval, and distribution of study-related documents including Case Report Forms (CRF’s), study manuals, and other study tools to investigational sites and review committees.(email for modified version)Drive study start up process across multiple studies inclusive of ICF review, budget negotiation and assists clinical sites with their IRB submission.Provide support to Project Management to establish and implement standard processes around clinical trial management.Collaborate with the Field and CTC teams 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 maintenance of Clinical infrastructure such as the drafting or reviewing SOP’s and Work Instructions. Provide regular 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 audits.What you bring
The desire to be part of a team that makes a difference.Highly developed leadership skills, with the ability to bring out the best in a team and its members.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) preferred, with at least 3+ years of related experience in clinical/scientific research, nursing, or an equivalent combination of education and experience.Extensive knowledge of the drafting and redlining of Informed Consent Form (ICF).Extensive experience working with sites to meet study endpoints and achieve set milestones.Excellent oral, written and interpersonal communication skills.A high degree of competency with spreadsheets, word processing and presentation programs.A knack for detail, problem solving and meeting deadlines. Project management experience highly desired.
What We Offer:
• 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 that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
