Position: Clinical Research Associate II (CRA II)
Location: U.S. (Remote with ~50% travel)
Industry: Medical Device
Experience Level: 2-5 Years
We’re seeking a driven Clinical Research Associate II (CRA II) to join our Clinical Operations team. In this role, you’ll support the successful execution of clinical studies by ensuring high‑quality site management, data integrity, regulatory compliance, and strong collaboration with field and in‑house teams. This position contributes directly to the advancement of important clinical trials and plays a key role in maintaining study quality and operational excellence.
What You’ll Do
Project Support
- Maintain the electronic Trial Master File (TMF) to ensure accuracy, completeness, and compliance with ICH/GCP and SOPs.
- Develop and review regulatory documents to support study start‑up and ensure site readiness for initiation.
- Conduct study training for site personnel and verify proper adherence to protocols and regulations.
- Ensure investigational device accountability, tracking, and security at clinical sites.
- Review and ensure timely reporting of adverse events, concomitant medications, and other protocol‑required data.
- Identify, communicate, and help implement corrective actions for protocol or compliance deviations.
- Support query resolution and review Data Clarification Forms (DCFs).
- Assist with Investigator Meetings and training activities.
- Maintain regulatory documents and study supplies throughout the study lifecycle.
- Prepare study tracking systems and provide updates on document and site status.
- Perform quality checks on informed consent forms and related documents.
- Obtain and maintain IRB approvals (local and central).
- Support departmental initiatives including training and SOP updates.
- Independently manage responsibilities across multiple projects.
Team Coordination & Communication
- Participate in cross‑functional team meetings to track milestones, highlight risks, and support mitigation planning.
- Prepare meeting agendas and minutes when needed.
- Generate and distribute study status reports.
- Share lessons learned and best practices with internal teams.
Functional Support
- Contribute to continuous improvement initiatives within Clinical Operations.
- Support quality teams during external clinical trial audits.
- Collaborate with Finance/Accounting/Clinical Trial Management to provide documentation for site payments.
What You Bring
- Bachelor’s degree (science or healthcare discipline preferred).
- Minimum 3-5 years of clinical research coordinator experience with 1-2 years of clinical monitoring experience.
- Strong understanding of ISO, GCP, ICH, FDA, and other applicable clinical research regulations.
- Experience with document control (TMF, protocol/ICF revisions and amendments).
- Proficient in Microsoft Word, Excel, PowerPoint.
- Solid understanding of medical terminology and clinical trial processes.
- Ability to independently manage workload and problem‑solve in real time.
- Strong communication, organizational, and time‑management skills.
- Detail‑oriented, proactive, and effective at juggling multiple priorities.
- Ability to travel up to 50%
- Close proximity to major airport.
Preferred Qualifications
- Experience supporting device trials (if applicable).
- Experience in ICU environment.
- Prior involvement with site monitoring and close-out activities.
- Familiarity with risk‑based monitoring tools or eTMF systems.
- Experience mentoring junior staff.
Ready to make a real impact in patients’ lives and help bring life-changing therapy to the world? Send your resume and cover letter to [email protected] today and join Lungpacer’s mission to redefine respiratory support. Your clinical expertise and passion for patient care can help shape the future of medicine.
