Research Nurse Coordinator

Research Nurse Coordinator, Oncology skills preferred(07-0923)GENERAL SUMMARY OF POSITION: Under general supervision of the Principal Investigator, the Research Nurse Coordinator II is responsible for managing complex protocols testing investigational drugs, devices or research interventions. Takes primary responsibility for study protocol conduct, acting as a liaison between investigator, institutional review board and sponsor to ensure good clinical practice standards (GCP) throughout life cycle of the study.MAJOR RESPONSIBILITIES: o Maintain and manage all aspects of complex study conduct, including data and source documentation, adverse event reporting and communications with institutional review board (IRB)o Take primary responsibility for creation and maintenance of all regulatory documents, including initial IRB submission, continuing review submissions and FDA and sponsor required regulatory documentso Provide feasibility assessment of research study according to protocol requirements and design a recruitment plan for specific clinical study o Assess study budget and recommend changes and adjustments as necessaryo Screen patients according to study criteria; randomize, enroll and consent in accordance with GCP standards o Schedule, perform and/or coordinate all study procedures according to protocol requirements and sponsor conventionso Work with investigational pharmacy to ensure proper adherence to randomization schema, study drug dosing and administration per protocol o Perform nursing assessment of study participants according to protocol and consult with clinician or principal investigator as necessaryo Document and record, in writing or electronically, all study events and protocol related procedureso Assist in collation, writing and editing of research results in collaboration with Principal Investigatoro Review and abstract medical records information in a consistent manner, in accordance with study protocol and institution?s HIPAA requirementso Maintain patient/subject confidentiality and strictly adhere to all federal, state and institutional standards for GCP o Maintain business confidentiality as it relates to sponsor and/or investigator?s protocolo Attend meetings, conferences and seminars as required o Adhere to all institutional health, safety and infection control regulations and requirementso Perform additional duties as trained and required by study protocolsTo apply:Apply online using this address: http://www.jobs-umassmed.org/umm/jobboard/JobDetails.aspx?__ID=*696BA901BB15EC56Resumes may also be mailed or faxed to: Human Resources, University of Massachusetts Medical School, 333 South Street, Shrewsbury, MA 0545, 508-856-2390. Please reference code 07-0923About UMMS:At the University of Massachusetts Medical School, we take seriously our mission to serve the people of Massachusetts. We do this by achieving national distinction in health sciences education, research and public service. In the area of research, UMMS has achieved world-class status. Research is conducted in the laboratory, ambulatory clinic and at the bedside, contributing significantly to medical science and to the state's economy, as well as enhancing our ability to attract outstanding faculty members for all three schools. Extramural research funding totals over $174 million, placing UMMS in the top 40 among the nation's medical schools in funding. We are also proud to have been awarded the Nobel Prize in 2006 in Physiology or Medicine for 2006 for Craig C. Mello, PhD, and his colleague Andrew Fire, PhD, of Stanford University, for their discoveries related to RNA interference.Benefits at UMMS:We offer highly competitive salaries based on experience and education. In addition, we offer an excellent benefits package including work/life balance programs consisting of meals-to-go, offsite UMass run day care centers, nursing mother rooms, lunchtime seminars, Flexible Work Options, and 3 dry cleaning drop off sites. Also, we offer state retirement, generous time off policies, 13 paid holidays, paid continuing education, health, dental and vision coverage. As an equal opportunity and affirmative action employer, UMMS recognizes the power of a diverse community and encourages applications from individuals with varied experiences, perspectives and backgrounds.Requirements: MINIMUM QUALIFICATIONS: o Bachelor?s degree in nursing (preferred) and RN with a minimum of five years of relevant nursing experienceo Two years of Research Nurse Coordination experience preferredo Oncology research experience strongly preferredo Current registration to practice nursing in the Commonwealth of Massachusetts o Certification as CRC preferredo Strong oral and written communication skills; attention to detail essentialo Phlebotomy and EKG skills preferredo Ability to work in a team environment to facilitate integrity of study and its timely completiono Ability to manage a protocol from its inception to completion and problem-solve difficulties in its life cycleo Normal visual acuity, hearing and manual dexterity; must be able to perform all essential functions of this position with reasonable accommodation if disabled