Research Nurse Coordinator

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 Site Director, the RNC uses advanced clinical expertise and specialized research experience to move complex inpatient and outpatient study protocols from start-up through site initiation, active coordination, and study close-out. The RNC is the central operational contact for assigned studies, connecting sponsors, Principal Investigators, and internal hospital departments. The position balances specialized clinical patient care with data tracking, regulatory compliance, participant recruitment, operational planning, and milestone verification, while adhering to applicable regulations, Good Clinical Practice (GCP), IRB requirements, and Regional One Health policies. The RNC coordinates sponsor relations, feasibility assessments, budgets, research-service rates, supplies, training, study logistics, monitor visits, and financial milestone documentation. Clinical duties include screening and educating participants, conducting informed consent, performing protocol-mandated nursing procedures, managing investigational products and medications, monitoring safety, and processing specimens. Regulatory and data duties include maintaining study records and regulatory binders, preparing IRB submissions and renewals, coordinating hospital approvals, tracking enrollment and trial milestones, completing case report forms, resolving data queries, and supporting monitoring visits and audits.

Requirements

Graduate of an approved nursing school or program.
Current Registered Nurse license to practice in Tennessee, or applicable compact-state licensure.
At least 3 years of clinical experience as a Registered Nurse.
At least 1 year of experience coordinating study activities and conducting multiple concurrent industry-sponsored clinical trials.
Ability to perform protocol-mandated clinical tasks within the RN scope of practice.
Ability to complete assigned clinical research coordination duties and comply with applicable research regulations, GCP, IRB requirements, and institutional policies.

Nice To Haves

Bachelor of Science in Nursing (BSN).
At least 2 years of directly related experience.
Strong clinical research regulatory expertise, including direct experience preparing and submitting IRB study applications.
Experience working with IRB communications.
Bedside nursing experience in an acute inpatient setting such as an ICU, Emergency Department, or Trauma.

Responsibilities

Serve as the primary operational contact between study sponsors and the site during study start-up; manage correspondence and coordinate meetings about protocol requirements and procedures.
Analyze protocol schedules of events and collaborate with budget personnel to ensure study procedures and clinical activities are reflected in study budgets.
Prepare research-services rate requests and work with internal and external departments to determine clinical charge rates for contract development.
Identify protocol-specific supplies, kits, and equipment; incorporate them into budgets, requisition supplies, and verify availability before study activities begin.
Coordinate and lead protocol-specific training for investigators, clinical pharmacy personnel handling investigational new drugs, and ancillary staff before study activation.
Partner with Principal Investigators to assess operational feasibility and complete site questionnaires for prospective trials.
Notify the Director of new clinical-trial inquiries and feasibility requests so institutional capacity can be assessed before setup begins.
Coordinate rooms for subject visits, monitoring spaces, and logistics across protocols and internal clinical research centers and ancillary departments.
Obtain cost estimates and plan research infrastructure logistics with hospital entities, including pharmacy and laboratory services.
Work with the Research Accounting Coordinator to verify documentation of study milestones and completed activities, including IRB approvals, to support accurate sponsor invoicing and timely billing.
Coordinate sponsor and study-monitor visits, including facility access, IT/EMR permissions, and conference space.
Review inpatient and outpatient medical histories, abstract EMR chart data, and evaluate physiological variables to identify eligible clinical trial participants.
Educate and orient physicians, nurses, patients, and families about study procedures, therapeutic mechanisms, study requirements, and clinical care.
Lead study-specific informed consent with the PI and document discussions in the EMR using approved PowerForms.
Perform protocol-mandated nursing tasks within RN scope of practice, including vital signs, EKGs, peripheral IV insertion, and urinary catheterization for specimen collection.
Plan, receive, store, and inventory investigational products with Clinical Pharmacy, including biologics, medical devices, and drugs.
Prepare and administer study medications or placebos and monitor subjects for immediate and delayed adverse reactions.
Review laboratory results, track and document adverse events and serious adverse events, and report unusual occurrences or safety concerns to the PI and Director.
Draw blood, assist physicians with specialized operating-room specimen collection, and operate laboratory equipment such as centrifuges to process, store, and ship specimens in accordance with IATA and protocol requirements.
Build, update, and maintain regulatory binders and study records, including documentation for protocols, amendments, and Investigator Brochures.
Prepare and submit initial IRB applications, revisions, and annual renewals, and oversee application documents drafted by supporting research personnel.
Verify that contract language aligns with the Informed Consent Form's payment and compensation-and-treatment-for-injury sections when Regional One Health holds the contract; draft and upload clearance letters for initial IRB submissions.
Consult with the Director before initial IRB submissions to confirm contracts and budgets are finalized.
Compile IRB-approved documents and complete Regional One Health research application forms for administrative hospital approval.
Create and maintain trial tracking databases covering initiation dates, contract status, IRB and hospital approval tracking, and accrual metrics.
Maintain compliant subject enrollment records, including enrollment dates, randomized groups, consent documentation, and study completion or termination dates.
Complete case report forms, manage and clean clinical data, and resolve data queries and related issues.
Prepare source documentation, host sponsor monitors, and coordinate internal or external site audits and query resolution.
Complete mandatory online training and maintain active certifications for assigned study modules, including GCP.
Attend assigned investigator meetings and provide ongoing protocol training and in-services for research personnel and ancillary hospital staff.
Perform other clinical research coordination duties as assigned or required to support the Office of Medical Research.