GENERAL SUMMARY OF POSITION: 

Under the general supervision of the Principal Investigator or designee, the Nurse Practitioner is responsible for independently carrying out multiple complex research protocols designed to test the safety and/or efficacy of investigational drugs, devices or procedures; select and monitor test populations; administer drugs (investigational or otherwise as needed); collect and analyze data; report findings to principal investigator, drug company, device company and IRB when necessary.

MAJOR RESPONSIBILITIES:

• Administratively responsible for recruiting, screening, assigning, maintaining and terminating study subjects
• Schedule, perform, and supervise all patient tests
• In conjunction with the drug manufacture’s protocol, performs admission testing, diagnostic procedures, laboratory work, drug administration and out-patient follow-up, including procuring, preparing and packaging blood specimens
• Assist in the development of SOP’s
• Assist in development of research protocols, case report forms and case report form completion guidelines
• Obtain patient histories and perform physical exams
• Communicate findings in a comprehensive and organized fashion verbally and in writing
• Consult with physician and monitor medication regime.  Prescribe medication when necessary
• Independently makes decisions regarding patient care in absence of principal investigator
• Review new research protocols to assess for feasibility
• Act as a consultant for coordinators and principal investigators from various departments
• Assist in the design, development and implementation of other research endeavors with multiple departments
• Negotiate budget and selective aspects of the clinical study agreement with the sponsoring agencies for clinical trials
• Coordinate all aspects of study protocols efficiently and in expected timeframe.
• Negotiate costs for services with laboratory/outside vendors
• Responsible for all regulatory paperwork for study initiation and continuation at UMMS (includes application for IRB, informed consents etc.)
• Ensure that all federal requirements for the conduct of clinical trials are met and oversee all regulatory aspects of the research protocols
• Responsible for the formal orientation of nurses, residents, and attending physicians to the conduct of clinical trials
• Responsible for the budget/operational aspects, ie prepare invoices for services rendered, submit journal entry forms to financial services, process incoming payments, and prepare and maintain the budgetary records for clinical research grants
• Supervise Research Staff
• Obtain consent from patients/next of kin for participation in clinical trials
• Comply with all safety and infection control standards appropriate to this position
• Perform other job related duties as required and assigned. 

REQUIRED QUALIFICATIONS:

• Bachelor’s Degree in NURSING and seven years of clinical nursing experience
• Licensed Nurse Practitioner
• Current registration in NURSING to practice in the Commonwealth of Massachusetts. 
• CCRC Certification.
• GCP Training
• ACLS Certification
• Exercises knowledge of federal requirements for the conduct of clinical trials
• Certification to perform venipuncture and insert intravenous catheters
• Verbal and written communication skills necessary to interact with patients, staff and outside agencies
• Visual and hearing acuity to perform patient care and literature reviews 
• Experience in using computer-based tools (Word, Excel, Access, Outlook, PowerPoint, etc.)
• Ability to travel to off-site locations.