Registered Nurse Clinical Research Lead
Exeter-NH-03833-United States
Responsible for the implementation and conduct of clinical trials with investigational anti‑cancer agents, in collaboration with Physician. Oversight of program development, operational conduct, research account accounting, and adherence to FDA and other research related regulatory guidelines.
Requirements:
- 3 to 5 years of direct experience
- BSN
- RN license ‑ NH or other Compact State
- Clinical Research Certification
Responsibilities:
Collaborates with attending physicians and principal investigators to identify appropriate clinical trials for conduct and recruit eligible patients. Collaborates with Cancer Center nursing staff to provide nursing care to patients receiving therapy on a clinical research trial. Assures nursing staff understands how to administer investigational agents per protocol specifications.
Assists Principal Investigators (PI) in the process of assuring adequate informed consent. Coordinate study enrollment, protocol treatment and follow up care for patients participating in clinical trials.
Assures that blood sampling and specimen preparation is obtained per protocol specifications and monitors results. Ensures that drug dosing and sample collection times are followed and recorded. Oversees scheduling of patient laboratory and radiologic assessments, admissions and clinic visits.
Documents all aspects of study and therapy in the patient electronic medical record and any other required database. In collaboration with nursing and medical staff, assess patients for complications related to therapy. Communicates observations/findings to enrolling MD, study sponsor, and in the medical record.
Provides in‑service training and serves as a resource to other clinical personnel including physicians, nurse practitioners, nurses, pharmacists and allied health professionals. Provides patient teaching about research in general, their specific clinical trial and treatment they will be receiving, HIPAA regulations and any other information related to clinical trials.
Communicates with referring and affiliated physicians to ensure documentation of clinical findings throughout the clinical trial.
Establishes and maintains database of prospective/current patients on clinical trials. Establishes mechanisms to ensure complete and accurate data collection and documentation. Prepares and participates in clinical trials audits and reviews.
Attends tumor board, IRB, multidisciplinary clinics and participates in quarterly Cancer Committee. Prepares and submits clinical trial information for IRB submission and presents to IRB with PI. Gives required updates and summary.
Collaborate with department leaders and PI's to support and achieve research department objectives, develop strategic planning goals and identify operational process improvements. Ensure study compliance by understanding, developing and applying all relevant SOP's. Maintains NCI RCR investigator registrations and other relative research compliance documentation.
Facilitates trial contracting and budget negotiations with study sponsors. Fiscal responsibilities include process of both vendor and site payments, as well as billing of Account Receivables following contractual agreements.
PI273332463
