General Summary The CRA II assists in the execution of clinical studies sponsored by Penumbra 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.
Specific Duties and 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.
*Indicates an essential function of the role Position Qualifications 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) 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.
Additional qualifications: *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 *Intermediate level of competence in Word, Excel, PowerPoint or equivalent programs is required.
*Ability to work on teams and with multiple projects.
*Ability to provide guidance and mentoring to junior clinical staff.
Working Conditions *General office, laboratory, and hospital environments.
*Willingness and ability to work onsite and remotely.
Approximately 30-60% travel to research laboratories or hospitals, conferences and/or other Penumbra affiliated facilities.
*Potential exposure to blood-borne pathogens.
*Must be able to move between buildings and floors.
*Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
*Must be able to read, prepare emails, and produce documents and spreadsheets.
*Must be able to move within the office and access file cabinets or supplies, as needed.
*Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Annual Base Salary Range $88,715.66 - $129,569.00 This is the pay range for a mid-cost labor market.
If hired in another region, there will be a difference in pay range.
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 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).
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 Penumbra's AAP Policy Statement.