Clinical Research Nurse Coordinator
2 weeks ago
Nursing - Registered Nurse
Work Shift/Schedule:
8 Hr Morning - Afternoon
Northeast Georgia Health System is dedicated to enhancing the health of our communities.
About the Role:
Job Summary
The Research Nurse Coordinator is accountable for the organization, execution, and assessment of clinical research trials. This encompasses all stages of research: Study Initiation, Execution, Completion, and Administration. The role requires maintaining precise and thorough documentation of patient and study participant evaluation data. Responsibilities include strategizing recruitment efforts for study participants, enrolling them, and overseeing data collection and reporting for institutionally sanctioned research studies. It is essential to ensure compliance with enrollment requirements and maintain adherence from entry through follow-up, investigator involvement, data report submission, and audits.
Minimum Job Qualifications
- Licensure or other certifications: Current GA RN License.
- Educational Requirements: Associates Degree.
- Minimum Experience: One (1) to two (2) years of direct clinical RN experience. Less than one (1) year of RN experience may be acceptable upon Management review of experience and credentials.
- Other:
- Preferred Licensure or other certifications: Clinical Research Certification or scheduled exam date.
- Preferred Educational Requirements:
- Preferred Experience:
- Other:
- Comprehensive understanding of the Clinical Research Process
- Exceptional written and verbal communication skills
- Advanced Computer Skills, including proficiency in Windows, Excel, Word, and competency with databases
- Stays updated on knowledge and skills in clinical research
- Recruit and screen potential study participants.
- Develop and deliver patient and family education regarding research participation related to diagnosis, treatments, and protocol specifications.
- Conduct subject evaluations, administer investigational products, and provide nursing support.
- Gather study data, assist in creating data collection tools, study materials, and perform departmental in-services.
- Perform related responsibilities as required.
- Consult with the Research Manager regarding the study implementation process.
- Study Initiation: Plan, organize, and implement clinical trials/research studies to effectively meet goals and ensure timely completion of the study. Manage and communicate effectively with the Research Manager regarding proposed projects for feasibility, including analyzing scope of work, costs, and responding to inquiries and/or complaints. Review protocols for potential operational issues and make recommendations as needed. Create informed consents. Submit protocols, informed consents, and necessary documents to the Institutional Review Board (IRB) for approvals; maintain regular communication with the IRB as applicable. Attend IRB meetings for protocol review as needed. Confirm that all regulatory documents are submitted to the sponsor in a timely manner, e.g., 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as needed.
- Study Execution: Screen potential subjects for enrollment. Explain protocols and informed consents to subjects and obtain informed consents for subject participation. Oversee patient enrollment and follow-up.
Communicate with the Research Manager regarding resource needs and issues, e.g., supplies, equipment, etc.
- Study Completion: Complete study close-out procedures. Submit closeout documents to the sponsor and IRB. Compose year-end status reports for the Research Manager and research staff. Return study products, if applicable. Submit yearly post-study documents as required. Ensure study materials are stored and maintained for the appropriate timeline.
- Administration: Strong knowledge of MS Word, Excel, PowerPoint, and Outlook. Demonstrate the 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 the Research Manager.
- Create and promote positive team morale.
- Discuss role responsibilities, define performance expectations, provide ongoing feedback, and conduct regular performance reviews (verbal and written) as indicated by company policy with research staff members.
- Identify skill deficiencies and appropriate training work experience to eliminate skill gaps.
- 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 areas.
- Obtain information from the field on relevant new scientific developments that identify 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 requirements, 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 the Research Manager.
- Follow procedures should a protocol require medication prescriptions (i.e., written or phone-in) in that all requests will be given to the Research Manager for execution of such prescriptions. The Research RN will not phone in prescriptions for subjects.
- Perform other related job duties or functions as requested or assigned.
- Weight Lifted: Up to 50 lbs, Occasionally 0-30% of the time
- Weight Carried: Up to 20 lbs, Occasionally 0-30% of the time
- Vision: Moderate, Frequently 31-65% of the 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, Fingering, Driving
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.
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