Senior Research Nurse

6 days ago

Baltimore, Maryland, United States Johns Hopkins University Full time
Job Summary

We are seeking a highly skilled and experienced Senior Research Nurse to join our team at Johns Hopkins University. The successful candidate will provide research coordination support for complex early phase clinical trials conducted in the Drug Development Unit (DDU) in the Division of Clinical Pharmacology.

Key Responsibilities
  • Manage the day-to-day operations of the study, ensuring timely completion of tasks and milestones.
  • Maintain regular direct contact and close collaboration with study faculty, including discussions of possible study adverse events and safety concerns.
  • Participate in DDU weekly protocol review meetings, monthly conference calls with protocol sponsors, and annual project-specific meetings.
  • Work with study faculty to schedule medical coverage for screening prospective study participants and conducting study visit evaluations.
  • Oversee and support study visits for non-licensed DDU staff, including study coordinators and clinical research fellows.
  • Plan and manage all phases of study recruitment for assigned protocols.
  • Coordinate laboratory testing for study participants, including scheduling tissue biopsy procedures with Hospital clinical services, JHBR lab, and Clinical Pharmacology Analytical Laboratory (CPAL) staff.
  • Attend and assist physicians during tissue biopsy and fluid collection procedures.
  • Transport specimens to clinical and research laboratories.
  • Work with study pharmacists regarding possible protocol deviations and weekly anticipated dosing needs.
  • Assist in ordering research doses of radioisotopes from a commercial radiopharmacy.
  • Prepare for and participate in study monitor visits.
  • Track and coordinate regulatory materials needed for study continuation, including Institutional Review Board, Institute for Clinical and Translational Research, and Food and Drug Administration Investigational New Drug Applications.
  • Assist study investigators with drafting and revising protocol documents for NIH review.
  • Apply knowledge of and compliance with institutional and external clinical research guidelines, as well as DDU specific Standard Operating Procedures.
  • Assist in monitoring the data integrity of studies assigned to other research nurse coordinators using Quality Assurance forms maintained by the DDU.
  • Oversee the clinical assessments of study subjects, including screening, evaluation, and testing.
  • Develop workflow policies and procedures, including drafting clinical instruction sheets to follow study protocol evaluations.
  • Prepare study manuals and documents, including patient charts, specimen collection materials, clinical test logs, and specimen drop-off and documentation logs.
  • Provide direct clinical care to research participants within the scope of a nursing license.
  • Administer study medications.
  • Collect specimens, including phlebotomy, and place peripheral intravenous catheters.
  • Perform Point of Care (POC) testing.
  • Oversee data collection, processing, storage, inventory, and quality control.
  • Obtain informed consent under the general supervision of the investigators and educate participants regarding study requirements.
  • Participate in preparing complex data gathered during the clinical research study for analysis and interpretation.
  • Work with principal investigator to define information and plans required to accomplish individual protocol timelines and goals.
  • Regularly review data to ensure completeness, accuracy, and timeliness of data collection.
  • Provide training for new staff members in areas of coordinating clinical workflow with clinical trial management.
  • Schedule research follow-up appointments.
  • Monitor patient accrual and follow-up appointments.
  • Additional responsibilities include research medication administration; assessment for local and/or systemic reactions to study interventions; intravenous access placement and maintenance; blood sampling from intravenous access; medical history gathering; provision of counseling to reduce or avoid risk of blood-borne infections; phlebotomy; urine specimen collection; assistance with specimen preparation, storage, and transport; data collection and documentation; assistance with report generation and sponsor notification regarding adverse events and new-onset illnesses; maintaining nursing credentials and required university trainings.
Requirements
  • Registered nurse, licensed in the State of Maryland or the state where practicing.
  • Bachelor's degree in nursing or related discipline required. A master's degree is strongly preferred.
  • Minimum of two years' experience in the specialty or a related area required.
  • Additional experience may substitute for a bachelor's degree and related master's degree may be considered in lieu of experience.
Preferred Qualifications
  • Preferred experience in phlebotomy and peripheral intravenous catheter placement.

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