Job Category:

Nursing - Registered Nurse

Work Shift/Schedule:

8 Hr Morning - Afternoon

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: One (1) to two (2) years direct clinical RN experience. Less than one (1) year RN experience may be acceptable after Management review of experience and credentials. 

• Other:

Preferred Job Qualifications

• Preferred Licensure or other certifications: Clinical Research Certification or scheduled exam date.

• Preferred Educational Requirements:

• Preferred Experience:

• 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
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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 t