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We are seeking a Sr. Research Nurse who will provide research coordination support for complex early phase clinical trials conducted in the Drug Development Unit (DDU) in the Division of Clinical Pharmacology. This position requires a high level of knowledge combining clinical experience with research coordination and data abstraction. The Sr. Research Nurse will collaborate with the study’s clinical team and faculty to implement multiple research protocols and will oversee study related activities.

Specific Duties & Responsibilities

• The Sr. Research Nurse will manage the day-to-day operations of the study.

• Maintains regular direct contact and close collaboration with study faculty, including discussions of possible study adverse events and safety concerns that arise with study participants and prospective study participants.

• Participates in DDU weekly protocol review meetings, monthly conference calls with protocol sponsors, and annual project-specific meetings with contributions to decisions regarding protocol design and modifications, data collection forms, and methods of data capture.

• Works with study faculty to schedule medical coverage for screening prospective study participants and conducting study visit evaluations.

• Oversees and supports study visits for non-licensed DDU staff (e.g. study coordinator, clinical research fellow).

• Plans and manages all phases of study recruitment for assigned protocols

• Coordinates laboratory testing for study participants, including coordinating scheduling tissue biopsy procedures with Hospital clinical services, JHBR lab, and Clinical Pharmacology Analytical Laboratory (CPAL) staff.

• Attends and assists physicians during tissue biopsy and fluid collection procedures.

• Transports specimens to clinical and research laboratories.

• Works with study pharmacists regarding possible protocol deviations and weekly anticipated dosing needs.

• At the direction of the Clinical Pharmacology faculty, assists in ordering research doses of radioisotopes from a commercial radiopharmacy.

• Prepares for and participates in study monitor visits.

• Tracks and coordinates 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, as well as document requirements from study sponsors.

• Assists study investigators with drafting and revising protocol documents for NIH review.

• Applies 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.

• Oversees the clinical assessments of study subjects, including but not limited to screening, evaluation and testing.

• Develops workflow policies and procedures, including drafting clinical instruction sheets to follow study protocol evaluations.

• Prepares 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.

• Specimen collection, including phlebotomy, and placement of peripheral intravenous catheters.

• Performs Point of Care (POC) testing.

• Oversees data collection, processing, storage, inventory, and quality control.

• Obtains informed consent under the general supervision of the investigators and educates participants regarding study requirements.

• Participates in preparing complex data gathered during the clinical research study for analysis and interpretation.

• Works with principal investigator to define information and plans required to accomplish individual protocol timelines and goals.

• Regularly reviews data to ensure completeness, accuracy, and timeliness of data collection.

• As needed provide training for new staff members in areas of coordinating clinical workflow with clinical trial management.

• Schedules research follow-up appointments.

• Monitors 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.

Minimum Qualifications

• The individual must be a 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 are 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.

Classified Title: Sr. Research Nurse

Role/Level/Range: ACRP/04/MF

Starting Salary Range: $75,100 - $131,700 Annually ($100,000 targeted; Commensurate with experience)

Employee group: Full Time

Schedule: Monday-Friday, 8:30am-5:00pm

Exempt Status: Exempt

Location: School of Medicine Campus

Department name: ​​​​​​​SOM DOM Clinical Pharmacology

Personnel area: School of Medicine

Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.