Sub Investigator (Non MD)
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 the conduct of research according to federal and state regulations and guidance documents. The role completes required training, maintains knowledge of applicable regulations and study requirements, and performs delegated clinical procedures and trial-related decisions. It also supports clinical staff, manages subjects’ medical care, conducts safety assessments, and ensures study-related procedures and events are documented.
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 English verbal and written communication and comprehension skills.
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 monitoring for 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
