Clinical Research Nurse Coordinator II-Heart & Vascular Research
Clinical Research Nurse Coordinator II-Heart & Vascular Research40 hours per week (4-10 hour shifts) primarily between the hours of 6:30 AM - 5:30 PM. Responsibilities include on-call, off-hour, and weekend coverage to achieve protocol compliance and study success.Responsibilities: Reports to the Heart and Vascular Research Manager and works closely with other staff members as part of Heart and Vascular Research Team. Interacts with study sponsors and monitors as needed.Performs sophisticated research involving ingenuity and abstract thinking. Responsible for managing study conduct of multiple trials in accordance with federal and state regulations. Identifies, and recruits potential trial subjects. Presents trial details to patients and obtains informed consent. Educates patients regarding his/her rights as a research subject, alternatives of care and provides teaching specific to the protocol, drug, device, treatment and/or side effects. Coordinates the scheduling of tests and treatments required by the protocol. Monitors subject´s status and safety, reports adverse events or unanticipated problems to investigators and sponsors. Participates and prepares for sponsor and FDA audits. Responsible for creating study specific source documents as needed. Prepares, submits, and maintains regulatory documents and prioritizes workload. Incumbent is expected to perform other similar and related duties as assigned. Management has the right to change or add to the job responsibilities at any time. Requirements:Massachusetts Licensure as a registered professional nurse. Minimum experience of 2-5 years as RN required. Prefer 6 months research experience and critical care, cardiology or emergency room nursing experience. Certification in Clinical Research as well as Bachelor in Science degree preferred. Strong knowledge of GCP and FDA regulations, solid understanding of research principles, well-developed computer skills, ability to work independently and as part of a team, excellent communication skills, takes initiative in completing tasks, creative, detail-oriented, excellent organizational skills. This position requires a mix of medical, administrative, business, computer and patient-related responsibilities. **Hiring manager requests a resume be submitted along with a completed Online Application**