Clinical Research Nurse Practitioner

3 weeks ago


Brooklyn, New York, United States DM Clinical Research Full time
Job Description

The Sub-Investigator is accountable and responsible for ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of subject-generated data, and directing the conduct of research according to federal and state regulations and guidance documents.

Duties & Responsibilities
  • Completing DMCR-required training, including GCP and IATA.
  • Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
  • Maintaining a current, up-to-date curriculum vitae and current licensure to practice.
  • Assisting in managing the activities and performance of the clinical staff affiliated with the site.
  • Performing clinical-related procedures and/or making important trial-related decisions delegated by the Principal Investigator.
  • Performing clinical safety assessments and monitoring for study trial participation, including physical exams, EKGs, phlebotomy, and lab work evaluation.
  • Possessing a thorough understanding of the requirements of each protocol.
  • Managing the medical care of subjects and protecting the rights and welfare of subjects.
  • Ensuring documentation of study-related procedures, processes, and events.
  • Attending investigator meetings as necessary for study participation.
  • Any other matters as assigned by management.

Knowledge & Experience

Education:
  • Bachelor's or Master's in Nursing.
Experience:
  • Previous clinical research experience.
  • Nursing experience in a clinical setting.
Credentials:
  • Current nursing licensure in good standing (Nurse Practitioner).
Knowledge and Skills:
  • Basic clinical and patient care skills.
  • Knowledge of nursing and medical principles and techniques.
  • Clinical research knowledge.
  • Strong communication skills, both written and verbal.
  • Strong diagnostic skills.
  • Ethical and legal healthcare principles in patient care.

At DM Clinical Research, we are committed to upholding the highest standards of research integrity and subject safety.



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