The Sub-Investigator/Rater provides oversight in medical and clinical issues, as requested or required. The sub-investigator works with the Principal Investigator (PI) to evaluate clinical trials and ensure that all study-related procedures are completed in accordance with Good Clinical Practices (GCP). The sub-investigator performs critical trial-related procedures and makes important trial-related decisions when delegated by the PI. Sub-investigator is engaged in the informed consent process and has a significant role in the conduct of research. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study participants according to protocols, and for protecting the health, safety, and welfare of research participants. In addition, sub-investigator may also act as the study coordinator as indicated.
Essential Duties and Responsibilities:
Including, but not limited to the following:
- Provides participant consultations and education in an in- or out-patient setting under the direction of the PI in charge of the clinical trial.
- Conducts study-related physical exams and follow-up visits.
- Administer semi-structured test or rater scales as per protocol, not limited to CDR, ADAS-COG, MMSE, CSSRS, Cognitive Battery Test, ESS, and like validated scales.
- Reviews and adheres to assigned research study protocols.
- Works with the study-leading PI in evaluation and review of potential study participant eligibility.
- Maintains proper documentation in accordance with GCP.
- Ensures that all clinical activities are carried out in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
- Collaborates with multidisciplinary team members.
- Reviews lab results, imaging reports, and other study-specific reports.
- Reviews and verifies participant medical history collected by the Wake Research Staff/Clinicians.
- Communicates with the participant as well as the participant’s partner/informant/caregiver.
- Attend and successfully complete all training programs in a timely manner
- Attend, participate in, and complete ongoing conference calls, webinars, required meetings, and other professional development opportunities.
- Complete required necessary training, Good Clinical Practice (GCP) training, and any Sponsor required trainings.
- Conduct participant interviews following specific study protocols, FDA, GCP, ICH, and HIPAA Privacy guidelines.
- Maintains knowledge and education of all applicable rules, regulations, policies, laws and guidelines respective to their field and role.
- Support site operations for community outreach recruiting efforts and participant retention