Research Nurse Coordinator-Cambridge

Found in: Resume Library US A2 - 1 week ago

Worcester Massachusetts, United States University of Massachusetts Medical School Full time
Overview:
POSITION SUMMARY: 

Under the direction of the Principal Investigator or designee, the Research Nurse Coordinator is responsible to carry 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 3 levels of Research Nurse Coordinator) - candidates will be hired into the level commensurate with their experience.

 

This position is Hybrid - The onsite portion located in Cambridge MA

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

Sr Research Nurse:

Duties noted above plus:

Review new research protocols to assess feasibility

Administratively responsible for recruiting, screening assigning, monitoring, maintaining, and terminating study subjects

Communicate with outside vendors to obtain the services required to meet the need of the research protocol

Assume administrative responsibility for the assigned research group/study

Administratively responsible for scheduling, performing, and/or supervising required study tests

Orient, train, supervise, and coordinate the activities of and provide feedback to assigned Research staff

Responsible for the operational aspects of the clinical research implementation

Coordinate a protocol from its inception to completion and problem solve difficulties during it life cycle

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

Sr Research Nurse

Requirements for RNC I plus:

7-9 years of relevant nursing experience, 3 years of which must be research nurse coordinator experience

Additional Information:
This position is based in Cambridge MA

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