Clinical Research Associate II
Your Remote US Home Office /
General Administration – R&D Clinical /
Assists in the planning, design, and execution of clinical studies 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. To meet the needs of our current studies, candidates in the following states will be prioritized: TX, NC, Northeast Region.
Specific Duties and Responsibilities
•Participate in the monitoring functions in a clinical study including site management, qualification, initiation, routine monitoring, and final close out.*
•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.*
•May participate on R&D project teams representing Clinical Affairs in device design phase reviews and documentation creation and/or revision.
•Assist Clinical management with the development, negotiation, and execution of the site contract, budget, and payment plan.*
•Draft informed consents with supervision from line manager.*
•Provide oversight on device accountability, inventory, and distribution, device complaint/malfunction processing and tracking.*
•Based upon Clinical requirements, monitor ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting.*
•Prepare and participate in presentation of protocols and other study conduct requirements at study initiations including training at investigational sites when needed.*
•Participate in the distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Penumbra central file, and for audit readiness.*
•Provide mentoring to junior staff regarding protocols, site management/monitoring,etc.*
•Assist with developing/maintaining project timeline, managing study budget, and preparing routine operations reports.*
•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 management with regulatory submissions, and other reports as required.*
•Assists 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.*
*Indicates an essential function of the role
Minimum education and experience:
•Bachelor's degree required in Biological sciences or health-related field (e.g., Biology, Chemistry, Biochemistry, Nursing, Biomedical or Veterinary Sciences) preferred with three plus (3+) years of experience in clinical/scientific research, nursing, or medical devices/ pharmaceutical industry required, and one plus (1+) years of clinical monitoring experience, or equivalent combination of education and experience.
•Project management experience preferred
•Working knowledge of medical terminology required
•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
•High 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
Annual Base Salary Range: $75,345 - $118,646
We offer a competitive compensation package plus a benefits and equity program, when applicable.
Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
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, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP-Policy-Statement.