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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.
MAJOR RESPONSIBILITIES:
Assist the Principal Investigator in feasibility and budget assessments for research studies, recommend changes and adjustments as necessaryResponsible for the protocol specific training of the study team and clinical staffAssist in the development of research protocols, case report forms, and case report form completion guidelinesMaintain and coordinate all aspects of complex study conduct, including data and source documentation, adverse event reporting, and communications with the IRBIn collaboration with the Principal Investigator, assist in collation, writing, and editing of research resultsProvide feasibility assessment of research study protocol requirements and design a recruitment plan for assigned clinical studiesParticipate in Quality Assurance internal auditsTake primary responsibility for creation and maintenance of all regulatory documents, including initial IRB submission, continuing review submissions, and FDA and sponsor required regulatory documentsScreen patients according to study criteria, randomize, enroll, and consent in accordance with GCP standardsPerform nursing assessments of study participants according to protocol and consult with clinician or Principal Investigator as necessarySchedule, perform, and/or coordinate all study procedures according to protocol requirements and sponsor conventionsReview and abstract medical record information in a consistent manner, in accordance with study protocol, institutional, and HIPAA requirementsOrganize and maintain appropriate regulatory documents in accordance with sponsor and institutional standards throughout the life of the studyIn collaboration with the investigational pharmacy, ensure proper adherence to randomization schema, study drug dosing and administration per protocolResponsible for all regulatory paperwork and to report findings to the Principal Investigator, sponsor, and IRB when necessaryReview clinical system billing charges for accuracy and appropriatenessEnsure that all required study event and protocol related data is accurately and efficiently entered into the clinical trial management systemDocument and record, in writing or electronically, all study events and protocol related proceduresMaintain patient/subject confidentiality and strictly adhere to all federal, state, and institutional standards for GCPMaintain business confidentiality as it relates to sponsor, protocol and related regulatory documentsAttend meetings, conferences, seminars, and applicable training as requiredEnsure that all staff adhere to policies and procedures of any clinical site where study is being performed and adhere to all institutional health, safety, and infections control regulations and requirements.Perform other duties as required.REQUIRED QUALIFICATIONS:
RN with current registration to practice nursing in Massachusetts5-7 years of relevant nursing experience, 2 years of which must be research nurse coordinator experienceProficiency in electronic medical records and relevant computer softwareStrong oral and written communication skills, attention to detail is essentialAbility to work in a team environment to facilitate the integrity of the study and its timely completionMaintain annual clinical partner nurse compliance standardsAbility to travel to off-site locations.PREFERRED QUALIFICATIONS:
Bachelor’s degree in NursingExperience with OnCore and EpicPhlebotomy and EKG skillsBLS CertificationAbility to interface with other departments at UMMHC/UMMS and educational institutions throughout Central MassachusettsInfection control including contact tracingAbility to work in a supervisory/teaching role with nursing studentExcellent management, data collection and record-keeping skillProficient use of Microsoft Office 365 including Word, Excel, PowerPointWillingness to travel to throughout Central MassachusettsAbility to work independentlyPrevious experience in infection control, community or public health desiredFamiliarity with data analysis or collection software (REDCap® or other) is desired#LI-AT1
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UMass Medical School Core Competencies demonstrating the capabilities that are central across all UMMS positions that collectively contribute to UMMS success.
Freqently Asked Questions
Mastery in clinical assessments, research protocol adherence, and patient consent processes are integral for a Research Nurse Coordinator II. Proficiency in electronic medical records and coordination with multidisciplinary teams ensures smooth study execution and compliance with good clinical practice standards.
Advancement often involves moving into senior research nurse roles, clinical trial management, or specialized nursing leadership positions. Accumulating experience in complex protocol management and regulatory affairs can open doors to supervisory or educational roles within clinical research.
Daily tasks include coordinating study activities, liaising with investigators and IRBs, managing patient recruitment and assessments, ensuring regulatory compliance, and maintaining meticulous documentation. The role demands adaptability and close collaboration within Worcester’s healthcare network.
Worcester's growing biomedical and clinical research community heightens demand for skilled research nurse coordinators. Positions at institutions like UMass Medical School are competitive but offer opportunities for candidates with solid clinical research experience and regional licensure.
Beyond Massachusetts RN licensure, certifications in clinical research (such as CCRC) and training in Good Clinical Practice (GCP) are highly valued. Additionally, BLS certification and familiarity with electronic health record systems are often essential to meet regional compliance standards.
UMass Medical School leverages this role as a pivotal point in protocol execution, regulatory compliance, and multidisciplinary communication. The coordinator ensures studies meet rigorous standards while fostering collaboration between clinical partners and academic researchers.
Coordinators at UMass often navigate complex multi-institutional collaborations and adhere to stringent sponsor and IRB requirements. Balancing research rigor with patient-centered care in a teaching hospital environment requires advanced organizational skills and adaptability.
Salaries in Worcester for this position typically range from $75,000 to $90,000 annually, reflecting local cost of living and demand. This is competitive with national averages for mid-level research nursing roles, especially within academic medical centers.
The 'II' level often involves managing more complex protocols, greater autonomy in regulatory submissions, and mentoring junior staff. It requires deeper experience in clinical research coordination, enhanced critical thinking, and advanced communication skills.
This title signals advanced proficiency and reliability, positioning individuals for supervisory roles. It often entails leadership in protocol training, quality assurance audits, and acting as a liaison among stakeholders, thereby laying groundwork for managerial career steps.
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