Field Clinical Research Associate III

This is a fully remote position, open to applicants in United States.

📋 Description

• The Field Clinical Research Associate III is involved in the design and execution of clinical studies sponsored by Penumbra to evaluate the safety and effectiveness of products.

• Act as the site manager, ensuring timely data entry and resolution of queries, while maintaining high-quality data reporting and audit readiness at the clinical site.

• Engage in monitoring functions within clinical studies, including site management, qualification, initiation, routine monitoring, and final close-out visits.

• Oversee ongoing compliance with study protocols and adherence to global regulatory guidelines, including safety reporting, both onsite and remotely.

• Prepare and participate in presentations of protocols and other study conduct requirements during study initiation visits, including training at investigational sites when necessary.

• Manage device accountability, inventory, and distribution, including some oversight of device complaint/malfunction processing and tracking.

• Coordinate the distribution, collection, and tracking of regulatory documentation to ensure compliance at both the sites and Penumbra trial master file, ensuring audit readiness.

• Conduct site visits as needed, acting as a liaison for the company to swiftly and effectively address site-related issues.

• Assist the Clinical team in developing, approving, and distributing study-related documents including Case Report Forms (CRFs), study protocols, study manuals, and other study tools to investigational sites and review committees.

• Draft informed consents with minimal supervision from Clinical Management.

• Provide mentoring to junior staff regarding protocols, site management, and monitoring.

• Participate in maintaining project timelines and preparing routine operations reports.

• Collaborate in developing and/or maintaining Clinical infrastructure, including drafting or reviewing SOPs 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, adhering to applicable regulations, standards, and procedures within the Company.

• Ensure that other department members comply with the QMS, regulations, standards, and procedures.

• Perform additional work-related duties as assigned.

⛳️ Requirements

• A Bachelor’s degree is required, preferably in Biological sciences or a health-related field (e.g., Biology, Chemistry, Biochemistry, Nursing, Biomedical, or Veterinary Sciences), along with 5+ years of experience in clinical/scientific research, nursing, or the medical devices/pharmaceutical industry, and a minimum of 2+ years of clinical monitoring experience, or an equivalent combination of education and experience.

• Strong understanding of medical terminology is required.

• Preferred strong knowledge of laws, regulations, standards, and guidance governing the conduct of clinical studies.

• Excellent verbal, written, and interpersonal communication skills are essential.

• Strong organizational and problem-solving abilities with the capacity to prioritize assignments while managing multiple projects; a keen attention to detail is necessary.

• Advanced proficiency in Word, Excel, PowerPoint, or equivalent software programs.

• Capability to work effectively within teams and handle multiple projects simultaneously.

• Ability to provide guidance and mentorship to junior Clinical staff.

🏝️ Benefits

• A comprehensive benefits package for eligible employees, which includes medical, dental, vision, life, AD&D, short and long-term disability insurance, a 401(k) with employer match, paid parental leave, eleven paid company holidays each year, a minimum of fifteen days of accrued vacation annually (increasing with tenure), and paid sick time per applicable laws.