Research Nurse Manager
GENERAL SUMMARY OF POSITION:
Under the direction of the Division Chief or designee, the Research Nurse Manager is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Research Nurse Manager 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.Responsibilities
- 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 department
- Manage 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 IRB
- Assist the Principal Investigator in feasibility and budget assessments for research studies, recommend changes and adjustments as necessary
- Establish 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 appropriate
- Design reports and extrapolate information from databases for analysis of operations.
- In collaboration with the Principal Investigator, assist in collation, writing, and editing of research results
- 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
- Schedule, perform, and/or coordinate required 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
- Oversight of clinical system billing charges for accuracy and appropriateness
- Accountable to 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.
- RN with current registration to practice nursing in Massachusetts
- 7 years of related experience preferably in clinical research, 3 years of which must be nursing management 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
- Maintain annual clinical partner nurse compliance standards
- Ability to travel to off-site locations.
- Master’s degree in Nursing
- SoCRA or ACRP certification
- Experience with OnCore and Epic
- Ability to insert intravenous catheters
- Phlebotomy and EKG skills
- BLS Certification