POSITION SUMMARY: Under the direction of the Division Chief or designee, the Clinical Research Physician Assistant is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Clinical Research Physician Assistant is a primary resource for study protocol conduct acting as a liaison between the University of Massachusetts Medical School (UMMS), clinical partners (ex. University of Massachusetts Memorial Health Care (UMMHC)), the Principal Investigator, Institutional Review Board (IRB), and sponsors to ensure good clinical practice standards (GCP) throughout the life cycle of the study.
ESSENTIAL FUNCTIONS: When necessary, work as an independent clinical practitioner to further the clinical research program of the Horae Gene Therapy Center.Manage research nurse coordinators, clinical research coordinators, and other related staff; responsible for hiring, training, performance management and supervision of all staff.Ensure compliance with research practice standards according to federal, state regulations and UMMS institutional policies and procedures.Monitor, evaluate and recommend changes with supplies, and equipment for the unit or departmentManage funding sources by monitoring revenue and expenditure activity in the appropriate clinical trials management, electronic medical records, and financial systems. Adhere to university, state and funding agency regulations.Oversight of all aspects of complex study conduct, including data and source documentation, adverse event reporting, and communications with the IRBAssist the Principal Investigator in feasibility and budget assessments for research studies, recommend changes and adjustments as necessaryEstablish and monitor unit/trial based quality assurance functions, correct deficiencies, investigate related incidences and complaints, prepare follow-up reports, and report to proper institutional or IRB representatives as appropriateDesign reports and extrapolate information from databases for analysis of operations.In collaboration with the Principal Investigator, assist in collation, writing, and editing of research resultsScreen patients according to study criteria, randomize, enroll, and consent in accordance with GCP standardsMaintain patient/subject confidentiality and strictly adhere to all federal, state, and institutional standards for GCPMaintain business confidentiality as it relates to sponsor, protocol and related regulatory documentsSchedule, perform, and/or coordinate required study procedures according to protocol requirements and sponsor conventionsResponsible for all regulatory paperwork in accordance with sponsor and institutional standards throughout the life of the study. Report findings to the Principal Investigator, sponsor, and IRB when necessaryOversight of clinical system billing charges for accuracy and appropriatenessAccountable to ensure that all required study event and protocol related data is accurately and efficiently entered into the clinical trial management systemAttend meetings, conferences, seminars, and applicable training as requiredEnsure that all staff adhere to policies and procedures of any clinical site where study is being performed and adhere to all UMMS institutional health, safety, and infections control regulations and requirementsPerform other duties as required.
REQUIRED QUALIFICATIONS: Graduation from accredited Physician Assistant Program with current registration to practice in Massachusetts7+ years of related experience preferably in clinical research. Proficiency in electronic medical records and relevant computer softwareStrong oral and written communication skills, attention to detail is essentialAbility to work in a team environment to facilitate the integrity of the study and its timely completionAbility to travel to off-site locations
PREFERRED QUALIFICATIONS:SoCRA or ACRP certificationExperience with OnCore and EpicAbility to insert intravenous cathetersPhlebotomy and EKG skillsBLS Certification