General Summary
Under general supervision, the Clinical Research Associate II IH assists in the planning, designing, and executing of clinical studies to assess safety and effectiveness of products. This position works with confidential subjects and company data, and interfaces with a variety of internal and external stakeholders.
Specific Duties and Responsibilities
•Drafts study-specific informed consent templates. *
•May assist management with developing/maintaining project timeline and preparing routine operations reports. *
•May assist with preparing the meeting materials to be presented at the study team meeting. *
•Assists 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. *
•Drives study start up process across multiple studies inclusive of ICF review, budget negotiation and assists clinical sites with their IRB submission. *
•Drives study amendment and closeout activities across multiple studies. *
•Motivates clinical sites to meet study endpoints and achieves milestones. *
•Provides support to Project Management to establish and implement standard processes around clinical trial management. *
•Collaborates with the Clinical Field team to identify areas for improvements in the site activation process. *
•Distributes, collects, and tracks regulatory documentation to ensure compliance at both the sites and Penumbra central file, and for audit readiness.
•Assists with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP’s and Work Instructions. Provides input only. *
•Provides periodic updates to management regarding site start-up progress. * Communicates potential or actual delays and proposes actions to ensure that project timelines are met. *
•May 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.
*Indicates an essential function of the role
Required Qualifications
Minimum education and experience:
•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
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.
Working Conditions
•General office environment
•Willingness and ability to work on site. May have business travel from 0% - 15%
•Potential exposure to blood-borne pathogens
•Requires some lifting and moving of up to 15 pounds
•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: $80,000 - $111,000
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.
