The Research Nurse will collaborate in recruitment and enrollment of participants, working with all subjects and caregivers in addressing their queries, concerns and arrangements for protocol, specific testing and procedures as well as overall continuity of care throughout protocol participation. Various administrative and regulatory accountabilities will be carried out by the incumbent, among other responsibilities as deemed necessary.
Completes informed consenting of research participants and works with PI to spear head novel intra and extra institutional recruitment and outreach initiatives. Assesses patient and caregiver (educational) needs about the informed consent process, protocol intervention procedures and its relationship to the disease process. Initiates one on one teaching and documents action for continuity of care through research protocol participation. Maintains patient rights and confidentiality with attention to safety concerns for the patient.
Reviews each protocol and case prior to enrollment and addresses questions or concerns to the appropriate personnel, specific to subject eligibility and participation (Principal Investigator, Study Physicians, Program Manger and/or Research Assistants). Provides supervision of Research Assistants and Coordinators.
Maintains effective participant follow up and documentation across all research protocols (progress notes, adverse event reporting and logging, and Con Meds), observing any changes in a patient's status and response to the protocol. Maintains effective communication with all members of the cross functional study team, at all times. Educates staff and research participants about the research study and interventions. Demonstrates ability to work independently within study guidelines.
Performs/assists in performing procedures within the scope of research project (phlebotomy, EKG, biospecimen processing of blood and CSF; assisting MD in completion of Lumbar Puncture, escorting participants to MRI and PET suites, etc).
Collaborates in completion of key regulatory submissions to local IRB, sponsor (NIA/NIH) and FDA.
Bachelor's degree in Nursing or equivalent in education and experience required. 4 years related experience
Must successfully complete online system training requirements
NYS RN License with current registration
Minimum 3 years prior experience coordinating clinical research trials (industry sponsored and/or investigator initiated).
Proficiency in using various Microsoft Office applications such as Word, Excel, Access, PowerPoint and Outlook.
Effective verbal and written communication skills, and strong analytical, organizational and interpersonal skills.
Ability to interface effectively with all levels of management and work and communicate effectively with both internal and external collaborators.
Ability to work within a team environment as well as independently.
Ability to manage time, multi task and prioritize work.
Ability to identify, analyze and solve problems; ability to work well under pressure.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 512844
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.