Identifying, enrolling, and consenting patients, and organizing study visits and follow-ups.
Ensure completeness, accuracy, and compliance with each protocol. Maintains regulatory binders in accordance with FDA and/or other applicable regulatory agency requirements.
Collaborates with principal investigator to open and implement clinical trials in accordance with protocol standards.
Works with physicians to update and implement clinical trials protocols in E.M.R.
Maintains current knowledge of applicable research standards for oncology, insuring that policies and procedures are current.
Participates in audits and monitoring visits by the project sponsors and/or regulatory agencies.
Completes all proper protocol documentation and assists in collection of data.
Provides education to clinical staff, patients, and families regarding protocols or study requirements, treatment plans, and side effects.
Identifies and leads research-related process improvement initiatives in the department according to quality measures and organizational goals.
Collaborates with other departments, including laboratory, pharmacy, radiology, and materials management as pertains to the implementation and ongoing management of clinical trials.
Monitors and reports adverse experiences and toxicities as required.
In collaboration with nurse manager of cancer services, interviews, selects and orients research support personnel.
Assumes responsibility for own personal continuing education and development needs, attends meetings, workshops and conventions to enrich personal knowledge and growth.
Participates in patient care conferences, educational, and tumor conferences. Attends research conferences and seminars.
Performs other work related duties and activities as assigned or requested.
Coordinate, evaluate and follow patient participation in clinical trials, including
Graduate of an accredited School of Nursing
Masters' degree in nursing or research preferred
Currently licensed as a Registered Nurse in the Commonwealth of Massachusetts.
Basic Life Support Certification required.
Must read, write and communicate in English.
Previous research coordination, data management, patient recruitment, and physician and interdisciplinary collaboration experience preferred.
Current chemotherapy/biotherapy card required upon hire and renewed every 2 years.
Must possess good oral and written communication skills.
Must demonstrate leadership abilities
Computer knowledge or able to learn various software applications.
Excellent organizational skills required.
Demonstrated skills in the education and counseling of patients and families.
Capable of working with terminally ill patients and their families.
ONCC (Oncology Nursing Certification Corporation) Oncology Certified Nurse (Must obtain within 2 years of hire).
ONS (Oncology Nursing Society) Membership preferred.
Good Clinical Practice (GCP) and Human Subject Protection (HSP) certification upon hire.
Cape Cod Healthcare Inc.