Sub-Investigator (Nurse Practitioner)
2 weeks ago
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 to include such items as: 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
Education:
- Bachelors or Masters 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
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