Title: Physician Assistant I Please make sure you read the following details carefully before making any applications. Location: Boston MA Schedule: M-F 8-5 onsite daily Terms: Direct Hire Start: ASAP Education: 4 years of college level education and bachelor's degree or equivalent. (BS/MS joint programs are also acceptable) Completed a Graduate Level, accredited Physician Assistant Program approved by AMA Board of Approval and Certification of PA programs. License/Certification: Board Certification by the National Commission on Certification of PAs (NCCPA) is required. License as a Physician Assistant in Massachusetts Maintain current DEA and Massachusetts Controlled Substance Licenses Requirements: - 0-2 years as a Physician Assistant I - Identify, recruit and consent eligible subjects for enrollment - Arrange and perform screening visits or prescreen by chart review. - Performs subject care according to mutually agreed upon practice guidelines, and in accord with current guidelines per state and hospital regulations. - Performs and records subject evaluations such as past medical history, social history and habits, review of systems, physical assessment, and discusses findings with Principal Investigator. - Oversees/assures completion of procedures and tests, particular to the trial population, which are mutually agreed upon with the supervising physician. Collaborates with Principal Investigators, research coordinators, and hospital personnel to safely implement the study protocol and coordinate resources. - Orders medications and writes prescriptions in accord with current protocol guidelines, organizational and regulatory policies and procedures. - Responsible for subject teaching, distribution of study medications, scheduling subject visits and follow-up visits as per protocol. - Monitor hospitalized subjects with daily visits and ensure high quality data collection. - Receives subject telephone calls, and is available by pager for questions from providers caring for study subjects - Communicate with the Principal Investigators and Director regarding study progress, enrollment, and lost-to-follow-up cases on a regular basis. - Incorporates the concepts of health maintenance, prevention, and promotion into daily practice through subject education and counseling. Responsibilities: - Oversee administrative procedures with the Institutional Review Board (IRB), other hospital groups and study sponsors. Assist in completing and submitting IRB applications as well as Annual Continuing Reviews. - Prepare for and represent for site visits and audits (Sponsor, monitor, FDA). Serves as primary contact for study monitor. Serves as lead for monitor visits and quality review of data and files. - Oversee system for tracking experimental drug supplies and appropriate storage. - Learn the process involving and maintain correspondence with, the IRB, FDA, and other regulatory agencies. Maintain files and computer databases on study participants. - Abstract data from patient's medical records for completion of research chart and case report forms (CRF). Complete, submit, and maintain case report forms in a timely manner. - Respond to queries regarding incomplete data, and serious adverse event (SAE) reporting. - Participates in departmental quality improvement program. Utilizes quality improvement data and research findings to enhance subject care. - Attend weekly staff meeting. #m3