Research Nurse Coordinator RN - Cardiology - 10 hour shift 6:30am-5:00pm
Company: Northeast Georgia Medical Center
Location: Gainesville
Posted on: April 2, 2026
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Job Description:
Job Category: Nursing - Registered Nurse Work Shift/Schedule:
Varies Northeast Georgia Health System is rooted in a foundation of
improving the health of our communities. About the Role: Job
Summary Responsible for the coordinating, implementing, and
evaluating of clinical research trials. This includes all phases of
research: Study Initiation, Execution, Completion, and
Administration. Maintains appropriate and accurate documentation of
patient/study participant evaluation data. Coordinates strategies
for recruitment of study participants, enrolls participants, and
manages data collection and reporting for institutionally approved
research studies. Ensures the requirements are met for subject
enrollment and compliance from entry through follow up,
investigator participation, data report submission and audits.
Minimum Job Qualifications Licensure or other certifications:
Current GA RN License. Educational Requirements: Associates Degree.
Minimum Experience: Minimum of five (5) years experience in
healthcare, preferably cardiology. Other: Preferred Job
Qualifications Preferred Licensure or other certifications:
Clinical Research Certification or scheduled exam date. Preferred
Educational Requirements: Preferred Experience: At least two (2)
years experience with the clinical trial process. Other: Job
Specific and Unique Knowledge, Skills and Abilities Thorough
knowledge of Clinical Research Process Excellent written and verbal
communication skills Advanced Computer Skills, including
proficiency in Windows, Excel, Word, and competency with databases
Remains current in knowledge and skills in clinical research
Essential Tasks and Responsibilities Recruits and screens potential
study participants. Develops and conducts patient and family
education regarding research participation as it relates to
diagnosis, treatments, and protocol specifications. Performs
subject evaluations, administers investigational product, and
provides nursing support. Collects study data, assists in
developing data collection tools, study materials, communication
and performs departmental in-services. Performs related
responsibilities as required. Consults with the Research Manager
regarding the study implementation process. Study Initiation: Plan,
organize, implement clinical. trials/research studies to
effectively meet goals and ensure timely completion of the study.
Manage and communicate effectively with Research Manager regarding
proposed projects for feasibility, including, analyzing scope of
work, cost and responding to inquiries and/or complaints. Review
protocol for potential operational issues and make recommendations,
as needed. Create informed consents. Submit protocol, informed
consents and necessary documents to Institutional Review Board
(IRB) for approvals; communicate with IRB on a regular schedule if
applicable. Attend IRB meetings for protocol review, as needed.
Confirm that all regulatory documents are submitted to sponsor in a
timely manner, e.g., 1572, Confidentiality Agreement, clinical
trial agreements, IRB approval letter, Financial Disclosures, etc.,
as needed. Ensure staff resumes and licenses are current.
Communicate with Research Manager regarding study initiation needs.
Identify needed storage space for study product. Develop study
specific materials, e.g., tracking logs, templates, monitoring
tools, source documents, study binders, process manuals. Study
Execution: Screen potential subjects for enrollment. Explain
protocol and informed consents to subject and obtain informed
consents for subject participation. Oversee patient enrollment and
follow-up. Be available for study “call” if needed. Maintain strong
working knowledge of Standard Operating Procedures (SOPs), FDA
regulations, and International Conference on Harmonization/Good
Clinical Practice (ICH/GCP) guidelines. Complete Case Report Forms
(CRFs) and study related documents, submit documents to sponsor
and/or IRB, if applicable. Ensure sponsor required documents are
completed, e.g., screening logs, Adverse event (A/E) forms, memo to
file, etc. Plan, organize, and participate in site initiation
visits and continued monitoring visits. Review the monitoring
reports with the Research Manager. Ensure studies are completed on
time and within budget. Communicate with outside vendors such as
central laboratories, central IRBs, etc. Provide guidance and
troubleshoot issues. Proactively address study concerns and develop
timely resolutions. Analyze and/or report safety issues, patients
care issues, and study design and/or study conduct issues. Ensure
that Adverse Events (AE) and Serious Adverse Events (SAE)
procedures are followed accurately and within federal regulations
and sponsor guidelines. Prepare study reports, e.g., modification,
amendments, Investigational New Drug (IND) reports, etc. Perform
yearly review of studies, completing yearly documents required by
sponsor, IRB and FDA. Review case report forms. Audit regulatory
binders. Ensure timely and accurate communication with the sponsor,
among research staff, and with the multiple functional areas with
Institution, e.g., via regularly scheduled calls, team meetings,
etc. Complete status reports and communicate with the sponsor,
research staff, Research Manager and Investigator(s). Work with the
key functional departments to coordinate the project-related
activities to meet project goals and milestones, based on the study
design. Ensure study data is submitted on-time to data management
for analyses. Ensure the statistical analysis plan is complete, if
applicable. Ensure information is available for final study report
completion. Communicate with Research Manager regarding resource
needs and issues, e.g., supplies, equipment, etc. Study Completion.
Complete study close out procedures. Submit closeout documents to
sponsor and IRB. Compose year end status report for Research
Manager and research staff. Return study product, if applicable.
Submit yearly post study documents, as required. Ensure study
material are stored and maintained for appropriate time line.
Administration. Strong knowledge of MS Word, Excel, PowerPoint and
Outlook. Demonstrate ability to prioritize multiple projects.
Proven ability to independently resolve problems. Requires strong
attention to detail in composing and proofing materials,
establishing priorities, scheduling and meeting deadlines. Work in
a fast paced environment with demonstrated ability to perform
multiple competing tasks and demands. Work independently, take
initiative and complete tasks to deadlines. Assist with maintaining
an updated training manual for research. Participate in the
training of other research staff as assigned. Track project
milestones and report progress and issues to Research Manager.
Create and promote positive team morale. Discuss role
responsibilities, define performance expectations, provide ongoing
feedback and conduct regular performance review (verbal and
written) as indicated by company policy with research staff
members. Identify skill deficiencies, and appropriate training work
experience to eliminate a skill gap. Attend SOP, IRB, GCP, ICH, and
FDA training sessions. Attend related courses, seminars, and
meetings. Ensure that skills are continually sharpened and that
learning and competency building are focused on routinely. Read
professional journals and publications to stay abreast of
regulations and study management and to learn scientific area.
Obtain information from the field on relevant new scientific
developments that identifies needs for staff training, if
applicable. Serve as a department resource for general study
related issues. Create and/or deliver project specific training to
ensure adequate training specific to project requirement, e.g.,
project overview, study protocol information. Assist in
providing/obtaining training that is role specific, e.g.,
monitoring GCP, ICH, SOPs and FDA. Provide needed assistance as
requested to effectively manage projects, schedules and deadlines,
vacation schedules, sick-leave, etc. Participate in
company-required training programs. Maintain time and attendance
records as directed by Research Manager. Follows procedure should a
protocol require medications prescriptions (i.e. written or
phone-in) in that all requests will be given to the Research
Manager for execution of such prescription. Research RN will not
phone in prescriptions for subjects. Performs other related job
duties or functions as requested or assigned. Physical Demands
Weight Lifted: Up to 50 lbs, Occasionally 0-30% of time Weight
Carried: Up to 20 lbs, Occasionally 0-30% of time Vision: Moderate,
Frequently 31-65% of time Kneeling/Stooping/Bending: Occasionally
0-30% Standing/Walking: Occasionally 0-30% Pushing/Pulling:
Occasionally 0-30% Intensity of Work: Occasionally 0-30% Job
Requires: Reading, Writing, Reasoning, Talking, Keyboarding,
Driving Working at NGHS means being part of something special: a
team invested in you as a person, an employee, and in helping you
reach your goals. NGHS: Opportunities start here. Northeast Georgia
Health System is an Equal Opportunity Employer and will not
tolerate discrimination in employment on the basis of race, color,
age, sex, sexual orientation, gender identity or expression,
religion, disability, ethnicity, national origin, marital status,
protected veteran status, genetic information, or any other legally
protected classification or status.
Keywords: Northeast Georgia Medical Center, Warner Robins , Research Nurse Coordinator RN - Cardiology - 10 hour shift 6:30am-5:00pm, Science, Research & Development , Gainesville, Georgia