Research Nurse Coordinator (6277)

REGIONAL ONE HEALTH•Memphis, TN

1d•Onsite

About The Position

The Research Nurse Coordinator (RNC) manages the implementation, daily operations, and compliance of multiple concurrent clinical trials within the Regional One Health Research Institute, LLC and Medical Research Services. Under the guidance of the Principal Investigator (PI) and the Site Director, the RNC utilizes advanced clinical expertise and specialized research experience to drive complex inpatient and outpatient study protocols forward from the initial start-up phase through site initiation, active coordination, and final study close-out. Serves as the central operational point of contact for assigned studies, the RNC bridges the gap between study sponsors, Principal Investigators, and key internal hospital departments. Ensures the absolute integrity and quality of clinical trials by adhering to federal, state, and local regulations, Good Clinical Practice (GCP) guidelines, Institutional Review Board (IRB) requirements, and Regional One Health policies and procedures. Responsible for balancing direct, specialized clinical patient care with meticulous data tracking, regulatory compliance, participant recruitment, startup operational planning, and milestone verification.

Requirements

RN - Registered Nurse - State Licensure and/or Compact State Licensure
Current license to practice as a Registered Nurse in the State of Tennessee Upon Hire Required
Minimum 3 years experience clinical experience as a Registered Nurse Required
Minimum 1 year experience coordinating study activities and conducting multiple concurrent industry-sponsored clinical trials. Required
Graduate of an approved nursing school/program Required
At least 2 years experience directly related Preferred
Strong clinical research regulatory expertise, including direct experience preparing and submitting IRB study applications. Preferred
Strong regulatory expertise and experience working with IRB communications Preferred
Previous bedside nursing experience in an acute inpatient setting (e.g., Intensive Care Unit / ICU, Emergency Department, or Trauma). Preferred

Nice To Haves

Bachelor's Degree BSN Preferred

Responsibilities

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.
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.
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.
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.
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.
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.
Promptly notifies the Director of all new clinical trial inquiries and feasibility requests to ensure proper alignment with institutional capacity before initiating setup activities.
Coordinates with internal clinical research centers and ancillary departments to secure rooms for subject visits, schedule monitoring spaces, and arrange logistics across multiple protocols.
Contacts internal hospital entities to obtain cost estimates and plan logistical frameworks for required research infrastructure, including pharmacy and laboratory services.
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.
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.
Reviews complex inpatient and outpatient medical histories, abstract EMR chart data, and evaluate physiological variables to screen, identify, and select eligible clinical trial participants.
Educates and orient physicians, nurses, patients, and families regarding individual study procedures, potential therapeutic mechanisms, study requirements, and general clinical care.
Leads the study-specific informed consent process alongside the PI, documenting detailed consent discussions within the Electronic Medical Record (EMR) via approved PowerForms.
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.
Plans, receives, and stores trial investigational products alongside the Clinical Pharmacy; manage active inventories of study-specific biologics, medical devices, and drugs.
Safely prepares and administers study medications or placebos; monitor subjects closely for immediate and delayed adverse reactions.
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.
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.
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).
Prepares and submits initial IRB applications, subsequent revisions, and required annual renewals; provide rigorous oversight if application documents are drafted by supporting research personnel.
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.
Consults with the Director prior to all initial IRB regulatory submissions to ensure study contracts and budgets are fully finalized.
Compiles all IRB-approved study documents and complete formal Regional One Health research application forms to facilitate administrative hospital approval.
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.
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.
Completes Case Report Forms (CRFs) accurately, manage and clean clinical data for analysis, and resolve data queries or related data issues efficiently.
Prepares source documentation for on-site monitoring, host sponsor monitors, and coordinate internal or external site audits to resolve queries.
Completes mandatory online training and maintain active certifications for all assigned study modules, including Good Clinical Practice (GCP).
Attends assigned investigator meetings and provide targeted, ongoing in-services or protocol training for supporting research personnel and ancillary hospital staff as needed.
Performs other clinical research coordination duties as assigned or required to support the Office of Medical Research.