In-House Clinical Research Associate
Employment Type: Full-Time
As an experienced member of our clinical research team, you will support the Clinical Study Manager and participate in the 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 clinical trials in the area of neurovascular or peripheral vascular therapies.
* 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.
* Monitor ongoing compliance with study protocols and global regulatory guidelines, including safety reporting.
* Prepare and deliver presentations of study protocols and other study requirements at site initiations, including training at investigational sites.
* Acting as a company liaison, work with clinical sites to provide training and resolve any site related issues quickly and effectively.
* Proctor cases as needed.
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.
* 4+ years of clinical research experience in the medical device space, including the monitoring of research sites.
* A Bachelor's degree in the life sciences or a health related field (e.g., Biology, Neuroscience, Biochemistry, or Nursing).
* 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 at the forefront of technology 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.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.