Department: Medicine/Clinical Pharmacology Work Schedule/Hours: Monday-Friday/8:30-5:00p/37.5 hours per week
The Sr. Research Nurse provides 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.
Duties & Responsibilities
The Sr. Research Nurse will manage the day-to-day operations of the study. Responsibilities include:
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.
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 and Clinical Pharmacology Analytical Laboratory (CPAL) staff.
Attends and assists physicians during tissue biopsy and fluid collection procedures. Works with study pharmacists regarding possible protocol deviations and weekly anticipated dosing needs.
At the direction of 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.
May assist in monitoring 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 work flow 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.
Performs Point of Care (POC) testing and assists with maintaining POC quality control as required by Hospital guidelines.
Oversees data collection, processing, storage, inventory and quality control for assigned protocols. Obtains informed consent under 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 provides of training for new staff members in areas of coordinating clinical work flow 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.
This description is a general statement of required duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
Individual must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline required. Master's degree strongly preferred. Minimum of two years' experience in the specialty or a related area required. Additional experience may substitute for bachelor's degree. Related master's degree may be considered in lieu of experience. Current American Heart Association or American Red Cross CPR certification required. Must maintain current licensure and certification during duration of employment. Acceptable completion of the JHH or BMC credentialing process is required within two weeks of start date.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
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