Sub-Investigator (Nurse Practitioner)
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; 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:
- Bachelors or Masters 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
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