Clinical Research Nurse Coordinator

StealthCo aims to bring life-changing treatments to more patients in need as a next-gen Integrated Research Organization.
Bringing highly trained on-site Clinical Research Coordinators together with an easy-to-use and easy to implement tech stack with best of breed tools and streamlined, centralized processes, StealthCo delivers high caliber trial site performance at AMCs, community hospitals, IPAs, private practices and more. If you’ve been looking for a chance to work with an amazing, highly motivated team and to have a direct impact in building a transformative clinical trials company every day – that is exactly what we’re offering. We provide competitive benefits and an environment focused on helping you grow personally and professionally.
You will work regionally in Irvine, CA and report to the Head of Site Operations.
About the Job:
As the Clinical Research Nurse Coordinator you will work collaboratively with the Principal Investigator and other StealthCo research staff to organize and facilitate study implementation in accordance with the study protocol, IRB regulations and Good Clinical Practice (GCP). You will coordinate the clinical logistics of research studies, apply clinical nursing background, research protocol knowledge, provide hands on treatment, monitoring, and follow-up of participants in clinical trials. Coordination includes all study procedures: recruitment, screening, scheduling, conducting visits, research participant data and specimen collection, traveling to perform on-site visits as required, performing phlebotomy and other assessments as required.
What you will do:

• Ensure adherence to federal and regulatory requirements in providing direct patient nursing care within the context of clinical trial implementation.
• Conduct study screening, enrollment, and follow up visits including assessments, completion of eCRFs, specimen collection, including, but not limited to: medical history, physical exam, review of systems, concomitant medications, perform ECG, perform study drug infusions, order protocol required labs, etc.
• With the Principal Investigator, assess signs and symptoms of potential Adverse Events (AEs) or Serious Adverse Events (SAEs) as defined in the protocol, with appropriate grading and attribution to likelihood of relation to study medication, in compliance with relevant oversight body; ensure reportable AEs/SAEs are reported as required within specified timeframe.
• Proactively communicate with study participants, providing education and responding to inquiries, while completing all study documentation, managing protocol deviations, and adhering to IRB and good clinical practice guidelines.
• Oversee participant lab results, follow up as required by protocol, and actively contribute to quality control and assurance activities in the study.
• Prepare for monitor and/or auditor visits by reviewing data and documentation; works with monitor to review study data and documentation as needed; works collaboratively with research team to respond to queries and questions during and following monitor visit.
  

What you will need:

• Minimum of 5 years of clinical research experience (including deep knowledge of human subjects’ protections and good clinical practice) in an academic, pharmaceutical, private physician’s office, or community-based clinic.
• Current California Board of Registered Nurse License, required.
• Bachelor’s Degree in Nursing or Health Science, preferred.
• Clinical research coordinator certification (e.g. ACRP, SOCRA) strongly preferred.
• Current AHA CPR Certification.
• Oncology experience in a nursing or clinical research capacity is required.
  

What you will bring to the table:

• Typing and computer skill/ability including word-processing, use of spreadsheets, email, and web-based data entry, eCOA and clinical trial technologies.
• Infusion and IP administration experience required.
• Ability to be flexible in handling/triaging unanticipated subject needs and situations.
• Demonstrated ability to work effectively with people of diverse races, ethnicities, nationalities, sexual orientations, gender identities, gender expression, socio-economic backgrounds, religions, ages, English-speaking abilities, immigration status, and physical abilities in a multicultural environment.
• You have led and built successful teams within a research environment.
  

Who you are:

• Administrator: You have a high detail-orientation, and never let things fall through the cracks.
• Collaborates: You work cooperatively with others across the organization to achieve shared objectives, partnering with others to get work done and crediting others for their contributions and accomplishments.
• Manages Ambiguity: You deal comfortably with the uncertainty of change, and are calm and productive, even when things are up in the air.
• Builds Effective Teams: You form teams with an appropriate and diverse mix of styles, perspectives, and experience, establishing common objectives and a shared mindset. You foster open dialogue and collaboration, creating a feeling of belonging and a strong team morale.
  

Additional Information:
Full-time base salary of $90,000-$120,000 plus equity.
Location: This position is regionally located in Irvine, CA.
Travel: May require regular travel to other research site locations within the region.
Exemption Status: Full time, exempt.