Research Registered Nurse

About the Role

Responsible for the performance of the research study under the medical supervision of the Principal Investigator. As a Clinical Research Coordinator III (RN), you will perform tasks independently, consistently, and accurately, demonstrating a moderate level of expertise in all skills and abilities to ensure high-quality work. This role involves complex study designs (phase 1-3 interventional trials) and associated procedures. You will apply a working knowledge of all facets of the role, relevant regulations, and organizational and departmental policies and procedures.

Responsibilities

• Protocol Comprehension and Implementation:
  • Coordinate care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines, and requirements.
  • Demonstrate understanding of protocol elements and execute study procedures.
  • Anticipate and mitigate potential protocol non-compliance.
  • Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires.
  • Assess subjects based on inclusion/exclusion criteria and evaluate/document subject eligibility independently.
  • Review draft informed consent documents in compliance with regulatory requirements and GCPs.
  • Conduct informed consent discussions in compliance with SOPs.
  • Review and interpret diagnostic test results and related documentation required per protocol.
  • Capture, assess, determine causal relationships of adverse events to investigational products, and report/follow up on adverse events.
  • Dispense study medication professionally and accountably following protocol requirements.
  • Maintain accurate records of receipt, inventory, distribution, and destruction of study-related materials, investigational products, and research specimens.
  • Ensure investigational drugs are received, stored, documented, and excess materials are returned to the sponsor according to guidelines and regulations.
  • Assess and manage compromised investigational products.
• Regulatory and Data Integrity:
  • Understand IRB/IEC review, key elements of review considerations, approval, and reporting requirements.
  • Complete all IRB/IEC-related documents over the course of a clinical study.
  • Maintain site credentials and ensure updated GCP, licenses remain on file.
  • Comply with reporting of safety-related subject discontinuation and safety concerns (AE, SAE, or AE of Interest) to the sponsor and IRB/IEC.
  • Autonomously collect, record, and report accurate data per FDA guidelines, reviewing them against patient medical records for completeness and accuracy.
  • Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
  • Manage monitoring visits, including preparations, support, documentation, and follow-up.
  • Maintain proper communication with monitors and follow up on all monitor requests.
  • Implement CAPA assessments and follow CAPA-related issues through to resolution.
  • Escalate issues of protocol non-compliance to the study PI and research department leadership.
• Research Financial Practices:
  • Assess protocols and study plans to develop study budgets.
  • Understand payment terms of study budgets and track items needing invoicing for clinical studies.

Requirements

• Education: Bachelor’s or Associate degree in Nursing is required.
• Certifications/Licenses:
  • Unencumbered RN License in the state of employment or multi-state license.
  • Valid state Driver’s License for travel to satellite offices and offsite meetings; compliance with company Driver Safety Operations and Motor Vehicle Records Check Policy is required.
• Previous Experience: 2-5 years of nursing experience required; oncology experience preferred.

Skills

• Analysis & Critical Thinking: Solid problem-solving, analysis, decision-making, planning, time management, and organizational skills. Detail-oriented with the ability to exercise independent judgment.
• Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation, and diversity awareness. Ability to work with sensitive and confidential material and emotionally charged matters.
• Communication Skills: Effective communication (oral, written, presentation), active listening, and providing balanced feedback. Good command of the English language; second language is an asset.
• Customer Service & Organizational Awareness: Strong customer focus, ability to build an engaging culture of quality and operational excellence through best practices, collaboration, and partnerships.
• Self-Management: Effectively manage time, conflicting priorities, stress, and professional development. Self-motivated with the ability to work independently with limited supervision and remotely as required. Ability to work in a fast-paced, multi-site environment with competing priorities.
• Computer Skills:
  • Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) required.
  • Prior experience with electronic medical records (EMR) preferred.
  • Prior experience with clinical trial data entry systems (EDC) preferred.
  • Prior experience with Clinical Trial Management Systems (CTMS) preferred.

Pay

Pay Range: $26.54 - $49.29 per hour

Sign-on bonus: $5,000

Schedule

Standard core workdays: Monday to Friday, 8:00 AM – 5:00 PM

Travel: 0%