Sub Investigator (Non MD)

Summary

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.DUTIES & RESPONSIBILITIESCompleting 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 evaluationPossessing 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 managementKNOWLEDGE & EXPERIENCEEducation:Bachelors or Masters in NursingExperience:Previous clinical research experienceNursing experience in a clinical settingCredentials:Current nursing licensure in good standing (Physician Assistant or Nurse Practitioner)Knowledge and Skills:Basic clinical and patient care skillsKnowledge of nursing and medical principles and techniquesClinical research knowledgeStrong communication skills, both written and verbalStrong diagnostic skillsEthical and legal healthcare principles in patient careProficient communication and comprehension skills both verbal and written in the English language are required.Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.#J-18808-Ljbffr

Job Description

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.DUTIES & RESPONSIBILITIESCompleting 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 evaluationPossessing 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 managementKNOWLEDGE & EXPERIENCEEducation:Bachelors or Masters in NursingExperience:Previous clinical research experienceNursing experience in a clinical settingCredentials:Current nursing licensure in good standing (Physician Assistant or Nurse Practitioner)Knowledge and Skills:Basic clinical and patient care skillsKnowledge of nursing and medical principles and techniquesClinical research knowledgeStrong communication skills, both written and verbalStrong diagnostic skillsEthical and legal healthcare principles in patient careProficient communication and comprehension skills both verbal and written in the English language are required.Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.#J-18808-Ljbffr