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Clinical Research Associate II (Field CRA)

1 week, 2 days ago
United States
Full-time
Mid Level
Operations Specialist
Project and Program Management
Apply Now
Penumbra

Penumbra

Penumbra Inc is a global healthcare company focused on innovating novel technologies to address challenging medical conditions in neuro and peripheral vascular markets. They design, develop, manufacture, and market medical devices for interventional th...

Health Care Providers & Services
1K-5K
Founded 2004
View All Jobs 25

Description

  • Manage clinical trial sites, including timely data entry, query resolution, data quality, and audit readiness.
  • Perform site qualification, initiation, routine monitoring, and closeout activities onsite and remotely.
  • Monitor protocol compliance, safety reporting, regulatory adherence, and provide site training as needed.
  • Prepare and present protocols and study requirements during study initiation visits.
  • Manage device accountability, inventory, distribution, and complaint or malfunction tracking.
  • Maintain regulatory documentation for clinical sites and the trial master file.
  • Conduct site visits and resolve site issues as a company liaison.
  • Support development and distribution of protocols, case report forms, study manuals, informed consents, and other study documents.
  • Draft or review SOPs and work instructions, maintain project timelines, and prepare operations reports.
  • Mentor junior clinical staff and promote compliance with the company QMS, privacy requirements, and applicable regulations.

Requirements

  • Bachelor’s degree in biological sciences or a health-related field, such as biology, chemistry, nursing, biomedical sciences, or veterinary sciences.
  • 3+ years of experience in clinical or scientific research, nursing, medical devices, or the pharmaceutical industry, plus 1+ year of clinical monitoring experience; equivalent education and experience may be considered.
  • Working knowledge of medical terminology.
  • Familiarity with laws, regulations, standards, and guidance governing clinical studies preferred.
  • Strong verbal, written, interpersonal, organizational, and problem-solving skills with close attention to detail.
  • Intermediate proficiency in Microsoft Word, Excel, PowerPoint, or equivalent programs.
  • Ability to work collaboratively across teams and manage multiple projects.
  • Ability to mentor junior clinical staff.
  • Willingness and ability to work onsite and remotely, with approximately 30–60% travel to research sites, hospitals, conferences, and company facilities.
  • Ability to work in office, laboratory, and hospital environments and potentially encounter blood-borne pathogens.

Benefits

  • Annual base salary range of $89,000–$130,000, adjusted by labor market and location.
  • Competitive compensation package with benefits and equity program when applicable.
  • Medical, dental, vision, life, AD&D, and short- and long-term disability insurance.
  • 401(k) plan with employer match.
  • Paid parental leave, 11 company holidays, at least 15 vacation days annually with increases based on tenure, and paid sick time.
  • Collaborative environment with ongoing learning and performance recognition.

Interested in this position?

Apply directly on the company website

Apply Now

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