Research Nurse Coordinator - Open Rank

out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Research Nurse Coordinator 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. This is an open-rank posting (there are 2 levels of Research Nurse Coordinator) - candidates will be hired into the level commensurate with their experience. Responsibilities ESSENTIAL FUNCTIONS: Research Nurse Coordinator I: Review and abstract medical record information in a consistent manner, in accordance with study protocol, institutional, and HIPAA requirements In collaboration with the investigational pharmacy, ensure proper adherence to randomization schema, study drug dosing and administration per protocol Participate in quality assurance internal audits Screen patients according to study criteria, randomize, enroll, and consent in accordance with GCP standards Maintain patient/subject confidentiality and strictly adhere to all federal, state, and institutional standards for GCP Maintain business confidentiality as it relates to sponsor, protocol and related regulatory documents Perform nursing assessments of study participants according to protocol and consult with clinician or Principal Investigator as necessary Document and record, in writing or electronically, all study events and protocol related procedures Identify adverse events according to study standards; triage, report, and document with the Principal Investigator according to IRB and sponsor requirements Schedule, perform, and/or coordinate all study procedures according to protocol requirements and sponsor conventions Responsible 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 necessary Review clinical system billing charges for accuracy and appropriateness Ensure that all required study event and protocol related data is accurately and efficiently entered into the clinical trial management system Attend meetings, conferences, seminars, and applicable training as required Ensure 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 requirements Perform other duties as required. Research Nurse Coordinator II: Duties noted above plus: Assist the Principal Investigator in feasibility and budget assessments for research studies, recommend changes and adjustments as necessary Responsible for the protocol specific training of the study team and clinical staff Assist in the development of research protocols, case report forms, and case report form completion guidelines Maintain and coordinate all aspects of complex study conduct, including data and source documentation, adverse event reporting, and communications with the IRB In collaboration with the Principal Investigator, assist in collation, writing, and editing of research results Provide feasibility assessment of research study protocol requirements and design a recruitment plan for assigned clinical studies Take primary responsibility for creation and maintenance of all regulatory documents, including initial IRB submission, continuing review submissions, and FDA and sponsor required regulatory documents Organize and maintain appropriate regulatory documents in accordance with sponsor and institutional standards throughout the life of the study Responsible for all regulatory paperwork and to report findings to the Principal Investigator, sponsor, and IRB when necessary Qualifications REQUIRED QUALIFICATIONS: RN with current registration to practice nursing in Massachusetts 3-5 years of relevant nursing experience Proficiency in electronic medical records and relevant computer software Strong oral and written communication skills, attention to detail is essential Ability to work in a team environment to facilitate the integrity of the study and its timely completion Ability to travel to off-site locations PREFERRED QUALIFICATIONS: Bachelor’s degree in Nursing Experience with OnCore and Epic Phlebotomy and EKG skills BLS Certification Research Nurse Coordinator II Requirements noted for RNC I plus: 5-7 years of relevant nursing experience, 2 years of which must be research nurse coordinator experience Organization Realize Your Opportunities – A Career at UMASS Medical School Inside Workings at UMASS Medical School The University of Massachusetts Medical School (UMMS), the Commonwealth's only public medical school, is proud of our role in serving the people of Massachusetts. Although, its the inside workings of UMMS that makes the difference. Mission and Culture We’re serious about our mission and about our people. Real World Impact - Our people get excited about our mission of real-world impact in health sciences education, research and public service. International Prominence and New Opportunities - As this institution has grown to national – and international – prominence, we’ve found new opportunities to train tomorrow’s physicians, nurses and scientists, discover causes of and cures for disease and help improve the quality of health care. Deep Commitment - With our clinical partner, UMass Memorial Health Care, and our other teaching affiliates, we share a deep commitment to national distinction in patient care. Valued Partnerships – UMMS partners with Commonwealth Medicine, the health care consulting arm of UMMS. Also, UMMS partners with MassBiologics in scientific collaborations, technology management and creating partnerships for the development of products for the benefit of patients. These valued partnerships help us to provide services and programs to help meet our needs at UMMS and the public. Proud Contributors - People at UMMS enjoy the feeling of going to work every day knowing what they do is truly important and worthwhile. Complementary and Inseparable - These varied parts of our mission and culture are complementary and inseparable. Careers UMMS, the state’s first and only public academic health sciences center, educates physicians, scientists and advanced practice nurses to heal, discover, teach and care, with compassion. UMMS is a world-class institution with opportunities to match. Competitive Compensation – UMMS offers salaries that are competitive with Worcester-area employers. When combined with our generous benefits, perks, and paid time off, many job seekers are surprised to find a total rewards package that matches or exceeds their current situation. Targeted Hiring Process – At UMMS, there are actually multiple hiring processes for different segments of our workforce. In nearly all cases, UMMS hiring process is decentralized, with qualified candidates screened and referred to an academic officer or manager with hiring authority. 24/7 Access to Employment Opportunities – iCIMS is our online job search and application system. iCIMS is available 24/7 to provide you with a convenient and up-to-date view of the available employment opportunities across our campuses. Updates are made daily and include all faculty and non-faculty position listings from every school and department within the UMMS. When you identify a position you are interested in and qualified for, apply online. New opportunities become available frequently so it pays to check back often! Benefits With outstanding benefits, competitive pay, extensive learning opportunities, and a stimulating and attractive work environment, UMMS may be exactly the employer you’ve been looking for. Superior Benefits - UMMS offers a wide range of benefits and perks that invite comparison with the best employers in the Worcester area – and with academic institutions anywhere. UMMS provides superior medical and dental coverage for you and your family, fully funded retirement plans, generous time off, a Tuition Assistance Plan – and much more. People Centered - UMMS is an employer, but it is also a community. Its comprehensive medical and dental benefits, retirement plans, and even paid holidays reflect an institution built around people, with a deep respect for their differences and needs. Commitment to Healthy Living - UMMS provides resources to help you balance work and life and encourages healthy living through great programs and discounts for fitness, physical activity, weight management, nutritional counseling and general wellness available through our health insurance plans. Breadth of Offerings - Above all, the breadth of UMMS offerings set the School apart and makes it an environment favored by all sorts of smart, career-savvy people. Apply for a Job 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. Online - To view all job opportunities and apply online, visit www.umassmed.edu/hr and click on the “Careers” tab. Start Now and Realize Your Opportunities! A History of Making Vital Improvements - UMASS Medical School Milestones 1962: Legislation establishes University of Massachusetts Medical School 1970: First medical students begin classes in Shaw Building 1974: First class graduates 16 MDs 1979: PhD program begins 1986: Graduate School of Nursing opens 1986: PhD program becomes Graduate School of Biomedical Sciences 1994: Graduate School of Nursing initiates PhD program 1998: UMass Clinical System and Memorial Health Care merge to form UMass Memorial Health Care 2001: Lazare Research Building opens 2002: Campus Modernization begins on the University Campus 2004: Graduate Entry Pathway Program established at the Graduate School of Nursing 2005: PhD Program in Clinical & Population Health Research established at the Graduate School of Biomedical Sciences 2005: Massachusetts Biologic Laboratories opens new manufacturing and filling facility in Mattapan 2006: Craig Mello, PhD, Blais University Chair in Molecular Medicine and Howard Hughes Medical Institute Investigator, is awarded the Medical School's first Nobel Prize. Dr. Mello shared the 2006 Nobel Prize in Physiology or Medicine with Andrew Fire, PhD, of Stanford University, for their discoveries related to RNA interference. 2007: Michael F. Collins, MD, is named chancellor and Terence R. Flotte, MD, is named dean of the School of Medicine. 2009: Groundbreaking for the Albert Sherman Center, a 500,000-square-foot research and education facility slated for completion in 2012. 2010: Ambulatory Care Center opens 2012: The Albert Sherman Center, a 500,000-square-foot research and education facility, completed and opens