Axle Informatics Nurse / Protocol Coordinator in Bethesda, Maryland
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
The Laboratory of Immune System Biology (LISB) at the National Institute of Allergy and Infectious Diseases (NIAID, NIH) is looking for a Registered Nurse at our Bethesda, Maryland location with expertise in Protocol Coordination.
Manage clinical protocols by training the study personnel; overseeing compliance to protocol; developing and adhering to relevant SOPs; managing the quality control, completion and submission of study related documentation; preparing, submitting and maintaining IRB, FDA, and/or other regulatory documents and research correspondence.
Monitor study enrollment goals and initiate strategies to promote enrollment and participant compliance.
Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, and overseeing study visits.
Obtain and document informed consent of participants.
Assess acute and non-acute clinical and research related problems and toxicities, communicate to physicians and report adverse events per protocol to sponsor and IRB.
Perform clinical and research-related procedures, including (but not limited to) patient scheduling; obtaining medical and family history; administering questionnaires.
Monitor and document clinical and research-related developments and response to therapy and communicate findings to principle investigators with recommendations for appropriate intervention.
Complete case report forms as per protocol (reports in NIH documentation system and to sponsor).
Assist nurse practitioners and physicians with specialized procedures and diagnostic examinations.
Observe and ensure the safety of human subjects while procedures are being performed.
Collect and ensure that sample volumes collected are within protocol, and ensure all samples are properly shipped.
Abstract medical information from medical history, medications and preexisting conditions for new participants.
Receive patient phone calls, furnish the requested information, or refer callers to the appropriate staff members.
Obtain medical records from primary care physicians and review medical records for enrollment eligibility. Review and prepare participant charts and record lab results for all new enrollments.
Prepare for and coordinate site visits made by sponsors or study monitors during the course of and at the close of the study.
Supervise and coordinate the collection, processing, shipment and storage of biospecimens.
Manage close-out of clinical protocols including audit preparation, trial closure, and communication with regulatory agencies, assisting in the final study report and completing financial obligations.
Nursing license is required.
Demonstrated significant depth and breadth of subject-level expertise.
Demonstrated awareness of the latest developments in the project specialty areas.
Ability to organize and prioritize assigned workload.
Excellent oral, interpersonal and written communication skills.
Innovative provider of creative solutions.
Enthusiastic, self-motivated and self-supervising team member.
Organizational ability to plan and deliver work to meet required deadlines.
Resilience in working to achieve team objectives and to overcome obstacles.
Demonstrated ability to be an effective team member.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
External Company URL: www.axleinfo.com