Clinical Research Nurse

3 days ago

Karachi, Sindh, Pakistan beBee Careers Full time

Job Summary

The Clinical Research Nurse will play a critical role in the conduct of clinical trials by providing expert nursing care and support for trial participants. This position ensures the safe and ethical conduct of clinical trials, adherence to study protocols, and compliance with regulatory requirements.

Responsibilities:

  • Provide direct nursing care to clinical trial participants, including administering investigational products and performing clinical procedures.
  • Conduct patient assessments, document medical histories, and monitor for adverse events (AEs) and serious adverse events (SAEs).
  • Ensure timely and accurate reporting of AEs/SAEs to investigators, sponsors, and regulatory bodies as required.
  • Educate participants and their families about trial protocols, procedures, and potential risks/benefits.
  • Obtain informed consent from participants in accordance with ethical and regulatory guidelines.
  • Provide oversight to all study-assigned nurses, ensuring adherence to protocols, regulatory requirements, and institutional policies.
  • Serve as a backup delegated nurse for all ongoing studies, stepping in as needed to ensure continuity of care and trial operations.
  • Maintain oversight of all clinical equipment, including their maintenance, calibration, and proper use.
  • Lead during Infection Control and other relevant audits.
  • Develop and deliver educational materials and sessions to enhance the skills and knowledge of the team.
  • Maintain compliance with ICH-GCP, Study protocol, institutional policies, IRB, etc.
  • Assist with the preparation and submission of regulatory documents, including IRB applications, amendments, and annual reports.
  • Conduct regular audits and monitoring to ensure trial operations align with institutional guidelines.

Requirements:

  • Bachelor's degree in nursing with a minimum of one year of work experience as a nurse in a hospital or related setting in inpatient and/or outpatient services.
  • Prior experience in working with research studies and/or oncology patient care will be considered an asset.
  • Excellent knowledge of nursing practice, strong clinical skills, and ability to perform complex nursing procedures.
  • Prior experience in operating basic medical equipment.
  • Critical thinking and problem-solving skills.
  • Sound working knowledge of Good Clinical Practice (GCP), clinical trial processes, and ethical considerations in clinical research.
  • Familiarity with IRB processes, informed consent, and health safety practices.
  • Excellent organizational and time management skills, with ability to manage multiple priorities and diverse tasks across multiple studies.
  • Proficiency in the use of computers, basic office software, and electronic data capture (EDC) systems.
  • Exceptional interpersonal and communication skills, both written and verbal.

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