The UMass Cancer Research Office (CRO) provides clinical trials administration to assist in the preparation and processing of all regulatory, contractual, and Institutional Review Board (IRB) documents related to institutional, cooperative group and pharmaceutical sponsored protocols for investigators within the CRO. The protection of human subjects is of paramount importance to the office, and a team of Regulatory Coordinators assist investigators with IRB submissions including new projects, continuing reviews, protocol revision, and adverse event reporting. Clinical trials coordination and data management are provided by research nurses, clinical research coordinators (CRCs), and/or data managers who work with the clinical care team to directly coordinate and facilitate all activities for patients involved in clinical research trials. The clinical research staff is divided into disease-based teams. Each clinical trial is assigned to a CRO principal investigator (PI) , a CRC and a research nurse; this research team is responsible for study coordination and data management of all aspects of that protocol.
The CRO is a shared resource that provides clinical research support services to investigators conducting cancer relevant clinical research. The CRO currently serves this function for the UMass Memorial Medical Center (Worcester, MA) and HealthAlliance Hospital (Leominster and Fitchburg, MA). As such, the office coordinates the vast majority of adult clinical research conducted in medical oncology, malignant hematology, benign hematology, neuro-oncology, radiation oncology, surgical oncology, and chemoprevention.
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.
- 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
- Maintain business confidentiality as it relates to sponsor, protocol and related regulatory documents
- 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 institutional health, safety, and infections control regulations and requirements.
- Perform other duties as required.
- 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
- Ability to travel to off-site locations
- Bachelor’s degree in Nursing
- Experience with OnCore and Epic
- Phlebotomy and EKG skills
- BLS Certification