Clinical Research Nurse Practitioner
3 weeks ago
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.
- Previous clinical research experience.
- Nursing experience in a clinical setting.
- Current nursing licensure in good standing (Nurse Practitioner).
- 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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