SEARCH CAREER OPPORTUNITIES

GENERAL SUMMARY OF POSITION: 

Under the direction of the Principal Investigator or designee, the Research Nurse Coordinator II is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Research Nurse Coordinator II 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 exciting opportunity to work under the direction of Principal Investigators from multiple different specialties in an autonomous role that involves direct collaboration and the opportunity to directly impact the health of patients through clinical trial research.  As the Department of Medicine Clinical Research Nurse, you will engage with investigators who are passionate about improving medicine in an academic environment that encourages innovative ideas to manage multiple clinical trials within the guidelines of the regulatory bodies.  The Clinical Research Nurse serves as the primary resource for investigators wishing to participate in clinical trials and utilizes expert knowledge and skills to perform the duties of the position, involving study start up and enrollment, regulatory communications with industry sponsors, budget creation and invoicing for services provided, data collection and entry, laboratory processing and shipping, and billing compliance in conjunction with the hospital and Office of Clinical Research. 

MAJOR RESPONSIBILITIES:

• 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
• Participate in Quality Assurance internal audits
• 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
• Screen patients according to study criteria, randomize, enroll, and consent in accordance with GCP standards
• Perform nursing assessments of study participants according to protocol and consult with clinician or Principal Investigator as necessary
• Schedule, perform, and/or coordinate all study procedures according to protocol requirements and sponsor conventions
• Review and abstract medical record information in a consistent manner, in accordance with study protocol, institutional, and HIPAA requirements
• Organize and maintain appropriate regulatory documents in accordance with sponsor and institutional standards throughout the life of the study
• In collaboration with the investigational pharmacy, ensure proper adherence to randomization schema, study drug dosing and administration per protocol
• Responsible for all regulatory paperwork and to 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
• Document and record, in writing or electronically, all study events and protocol related procedures
• Maintain patient/subject confidentiality and strictly adhere to all federal, state, and institutional standards for GCP

REQUIRED QUALIFICATIONS:

• RN with current registration to practice nursing in Massachusetts
• 5 years of relevant nursing experience, 2 years of which must be research nurse coordinator 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.

PREFERRED QUALIFICATIONS:

• Bachelor’s degree in Nursing
• Experience with OnCore and Epic
• Phlebotomy and EKG skills
• BLS Certification