A Clinical Investigator works on a clinical trial, and is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The Clinical Investigator must also meet requirements set forth by the FDA, EMA or other regulatory body. The qualifications must be outlined in a current resume and readily available for auditors.
Clinical Research Sub Investigator (Full Time or Part Time) Spectrum Research Institute, LLC Gilbert, AZ Job Details Part-time | Full-time 14 hours ago Qualifications Clinical compliance checks Electronic health records (EHR) management
HIPAA ICH
guidelines Data management Health record chart audits Research compliance clinical trial records management Advanced practice provider Research regulatory compliance Clinical quality assurance standards FDA regulations Documentation reviews Full Job Description Job Overview We are seeking an experienced highly motivated clinical research Sub Investigator to join our research team. Spectrum Research Institute, affiliated with Southeast Valley Gastroenterology, does clinical research related to gastrointestinal and liver disorders including fatty liver disease/MASH, inflammatory bowel disease, and cancer screening. Duties Support Principal Investigator in conducting clinical trials according to FDA regulations, ICH GCP guidelines, institutional policies, and study protocols. Supervise study staff and coordinate patient recruitment, screening, enrollment, and monitoring activities Perform study related procedures such as physical examinations, informed consent, subject history, adverse events, and subject health assessments. Review and hold expert knowledge of study related activities and protocols. Review and verify clinical documentation, including case report forms (CRFs), source documents, and regulatory files for accuracy and completeness Oversee patient monitoring procedures, including blood sampling, vital signs assessments, and adverse event reporting Requirements Licensed Physician Assistant or Nurse Practitioner 5-10+ trials as a sub investigator Certification in ICH GCP (Good Clinical Practice) Experience reviewing documentation related to clinical research projects for accuracy and regulatory compliance Proficiency with data management tools, clinical research platform (CRIO or similar), and electronic medical record (EMR) systems Familiarity with FDA regulations, HIPAA privacy rules, and clinical quality assurance standards
