Job Description |
- Recruit and screen patients using protocol inclusion/exclusion criteria. Refer eligible patients to the PI for final evaluation.
- Assign appropriate patient randomization number per protocol design.
- Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented.
- In collaboration with the Veterinarian, ensure that drugs are correctly administered as per protocol.
- Process and prepare specimens for lab analysis and shipping.
- Observe universal precautions and Occupational Safety & Health Administration (OSHA) standards when processing or handling specimens.
- Monitor laboratory results and consult with the PI for follow-up care.
- Ensure invasive hemodynamic monitoring is functioning appropriately and troubleshoot discrepancies where necessary
- Collect data in a timely and accurate manner and submit information to coordinating centers as required.
- Report adverse events to governing agencies and sponsors as required by protocol and regulations.
- Evaluate compliance of research subject and complete documentation of status and progress.
- Maintain detailed documentation of the research study including but not limited to individual patient files, databases as required by the protocol and the Investigator's File Binder/Regulatory Binder.
- Conduct literature searches in coordination with the NMCP library staff to ensure references are up to date.
- Prepare reports and other correspondence regarding the research protocol for the IRB and IACUC, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol.
- Interact on a regular basis with the PI and the Research Director regarding the conduct of the research study.
- Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency.
- Provide other administrative duties that are within the scope of work.
- Registered Nurse with a Bachelor's Degree or higher is required.
- A minimum of two years' experience coordinating research protocols certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).
- Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research.
- Clinical competence in application of professional nursing theory, practice, and skills for the care of patients.
- Ability to communicate effectively in written and oral modes and to teach in formal and informal settings.
- Skills in counseling, guidance and maintaining interpersonal relationships.
- Good typing skills to allow online documentation of patient interactions.
- Will complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and NHCL research integrity training within one month from start date and additional protocol specific training as required.