Clinical Research Associate II

General SummaryThe 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 QualificationsMinimum 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 …