Highlights

The role involves providing nursing care to study participants, monitoring patient safety, performing clinical assessments, managing adverse events, and maintaining accurate study documentation in compliance with clinical research protocols and regulatory guidelines. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Numbers & Facts

LocationChicago, IL

Description

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Research Nurse II
Location: Illinois
Duration: Long Term

Job Overview

We are seeking an experienced Research Nurse II to support Phase I clinical research studies. The role involves providing nursing care to study participants, monitoring patient safety, performing clinical assessments, managing adverse events, and maintaining accurate study documentation in compliance with clinical research protocols and regulatory guidelines.

Key Responsibilities

  • Participate in the execution of Phase I clinical research study protocols.
  • Maintain the safety, well-being, and confidentiality of study participants.
  • Monitor, evaluate, and report adverse events in a timely manner.
  • Review study protocols and informed consent forms and communicate potential issues to appropriate personnel.
  • Perform nursing procedures, including starting IVs, wound dressings, and clinical assessments.
  • Coordinate study-related nursing activities with the Principal Investigator, study physicians, screening teams, data systems, and other personnel.
  • Maintain accurate and complete source documentation in electronic source systems and other study records.
  • Identify and help resolve source data discrepancies and documentation issues.
  • Support participant recruitment, screening, and enrollment activities.
  • Follow study protocols, departmental SOPs, Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
  • Participate in quality improvement and compliance initiatives.
  • Assist with training new nursing personnel and monitor their progress.
  • Complete required orientation and training across all three shifts.

Required Qualifications

  • Active Illinois nursing license.
  • Minimum 1 year of nursing experience; new graduates are not eligible.
  • ICU experience preferred; telemetry or emergency room experience is also desirable.
  • Strong nursing skills, including IV starts, patient assessments, dressings, and computer-based documentation.
  • Ability to monitor patient safety and recognize and report adverse events.
  • Familiarity with clinical research protocols, informed consent, source documentation, and GCP guidelines is beneficial.
  • Strong communication, documentation, and coordination skills.
  • Ability to work night shifts, including every other weekend.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.

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