Research Nurse Coordinator (6906)

Research Start-Up, Logistics, & Sponsor Relations

• Sponsor Liaison & Site Representation: Serves as the primary operational point of contact between the study sponsor and the site during the start-up phase; manage correspondence and coordinate meetings to clarify complex protocol requirements, logistical details, and study procedures.
• Protocol-to-Budget Alignment: Analyzes the protocol's schedule of events to identify all required study procedures, tests, and clinical activities; collaborate closely with budget development personnel to ensure every operational cost is accurately captured in the study budget.
• Researches Rate Determination: Maintain a deep understanding of assigned study protocols and required clinical services to be rendered by ROH/ROHRI; prepare research services rate request forms and work with internal/external departments to determine appropriate clinical charge rates for contract development.
• Study Supply & Asset Management: Identifies all specific clinical supplies, kits, and patient care equipment required by the protocol; ensure these items are factored into the study budget, place requisitions for research supplies, and verify all essential components are onsite and verified prior to the initiation of study activities.
• Pre-Initiation Education & Training: Coordinates and lead protocol-specific training and educational in-services for site investigators, clinical pharmacy personnel handling Investigational New Drugs (INDs), and ancillary staff prior to study activation.
• Feasibility Assessments: Partners with Principal Investigators (PIs) to conduct rigorous operational feasibility assessments and complete site questionnaires to ensure the institution can accommodate and execute prospective trials.
• Pipeline Management: Promptly notifies the Director of all new clinical trial inquiries and feasibility requests to ensure proper alignment with institutional capacity before initiating setup activities.
• Operations Logistics: Coordinates with internal clinical research centers and ancillary departments to secure rooms for subject visits, schedule monitoring spaces, and arrange logistics across multiple protocols.
• Ancillary Coordination: Contacts internal hospital entities to obtain cost estimates and plan logistical frameworks for required research infrastructure, including pharmacy and laboratory services.
• Financial Milestone Verification: Collaborates directly with the Research Accounting Coordinator (RAC) to verify that all achieved study milestones (including IRB approvals) and completed study activities are properly documented with necessary supporting evidence, enabling accurate research invoice creation and timely billing to study sponsors by the finance department.
• Monitor Visit Coordination: Manages the practical planning and coordination of site visits by study monitors and sponsors, ensuring facility access, IT/EMR access permissions, and required conference spaces are secured.

Clinical & Patient Care Responsibilities (Complex & Inpatient)

• Screening & Selection: Reviews complex inpatient and outpatient medical histories, abstract EMR chart data, and evaluate physiological variables to screen, identify, and select eligible clinical trial participants.
• Subject Advocacy & Education: Educates and orient physicians, nurses, patients, and families regarding individual study procedures, potential therapeutic mechanisms, study requirements, and general clinical care.
• Informed Consent: Leads the study-specific informed consent process alongside the PI, documenting detailed consent discussions within the Electronic Medical Record (EMR) via approved PowerForms.
• Advanced Nursing Procedures: Performs protocol-mandated clinical tasks within the RN scope of practice, including vital signs, electrocardiograms (EKGs), peripheral intravenous (IV) line insertion, and urinary catheterization for specimen collection.
• Investigational Therapeutics: Plans, receives, and stores trial investigational products alongside the Clinical Pharmacy; manage active inventories of study-specific biologics, medical devices, and drugs.
• Medication Administration: Safely prepares and administers study medications or placebos; monitor subjects closely for immediate and delayed adverse reactions.
• Safety Monitoring & Toxicity Grading: Reviews laboratory results for abnormal values, track and document Adverse Events (AEs) and Serious Adverse Events (SAEs), and communicate unusual occurrences or safety flags directly to the PI and Director.
• Specimen Management: Draws blood, assist physicians with specialized specimen collection in the operating room, and operate lab equipment (e.g., centrifuges) to process, store, and ship biological specimens in compliance with IATA and protocol regulations.

Regulatory & Data Compliance Responsibilities

• Regulatory Binder Maintenance: Builds, updates, and maintains the primary regulatory binder and study records for each assigned trial, ensuring strict accountability for new protocols, amendments, and Investigator Brochures (IBs).
• IRB Applications & Renewals: Prepares and submits initial IRB applications, subsequent revisions, and required annual renewals; provide rigorous oversight if application documents are drafted by supporting research personnel.
• Contract/Consent Congruence: Confirms trial contract language perfectly matches the "Payment" and "Compensation & Treatment for Injury" sections of the Informed Consent Form (ICF) when ROH holds the contract; draft and upload accompanying clearance letters for initial IRB submissions.
• Pre-Submission Review: Consults with the Director prior to all initial IRB regulatory submissions to ensure study contracts and budgets are fully finalized.
• Hospital Approvals: Compiles all IRB-approved study documents and complete formal Regional One Health research application forms to facilitate administrative hospital approval.
• Trial Lifecycle Databases: Creates, populates, and maintains operational tracking databases for assigned trials to capture critical metrics including study initiation dates, contract statuses, IRB/ROH approval tracking, and overall accrual metrics.
• Subject Enrollment Trackers: Maintain detailed, compliant records of enrolled research subjects including enrollment dates, randomized study groups, consent documentation statuses (paper and EMR), and study completion or termination dates.
• Data Integrity: Completes Case Report Forms (CRFs) accurately, manage and clean clinical data for analysis, and resolve data queries or related data issues efficiently.
• Audits & Monitoring Visits: Prepares source documentation for on-site monitoring, host sponsor monitors, and coordinate internal or external site audits to resolve queries.
• Professional Development: Completes mandatory online training and maintain active certifications for all assigned study modules, including Good Clinical Practice (GCP).
• Training & Meetings: Attends assigned investigator meetings and provide targeted, ongoing in-services or protocol training for supporting research personnel and ancillary hospital staff as needed.
• Other Duties: Performs other clinical research coordination duties as assigned or required to support the Office of Medical Research.