Sub Investigator (Nurse Practitioner)
About The Position
The Sub-Investigator (Physician Assistant or Nurse Practitioner) 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 research conduct according to federal and state regulations and guidance documents. The role involves completing required training, maintaining knowledge of regulations and study requirements, assisting with clinical staff activities, performing delegated clinical procedures and trial-related decisions, and conducting safety assessments. The Sub-Investigator also manages subjects’ medical care, ensures study documentation, and attends investigator meetings as needed.
Requirements
- Bachelor’s or master’s degree in nursing.
- Previous clinical research experience.
- Nursing experience in a clinical setting.
- Current nursing licensure in good standing (Physician Assistant or Nurse Practitioner).
- Basic clinical and patient care skills.
- Knowledge of nursing and medical principles and techniques.
- Clinical research knowledge.
- Strong written and verbal communication skills.
- Strong diagnostic skills.
- Knowledge of ethical and legal healthcare principles in patient care.
- Proficient verbal and written communication and comprehension in English.
Nice To Haves
- Proficient bilingual (English/Spanish) verbal and written communication and comprehension skills.
Responsibilities
- Complete DMCR-required training, including GCP and IATA.
- Maintain working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
- Maintain a current curriculum vitae and current licensure to practice.
- Assist in managing the activities and performance of clinical staff affiliated with the site.
- Perform clinical-related procedures and make important trial-related decisions delegated by the Principal Investigator.
- Perform clinical safety assessments and monitor study participation, including physical exams, EKGs, phlebotomy, and lab work evaluation.
- Maintain a thorough understanding of each protocol’s requirements.
- Manage subjects’ medical care and protect their rights and welfare.
- Ensure documentation of study-related procedures, processes, and events.
- Attend investigator meetings as necessary for study participation.
- Handle other matters as assigned by management.
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What This Job Offers
Job Type
Full-time
