TheSub-Investigatoris 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 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

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

DM Clinical Research jobs

Sub-Investigator (Nurse Practitioner)