Clinical Research Nurse Manager

2 months ago

Gainesville, Florida, United States Northeast Georgia Health System Full time
Job Category:

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 role involves overseeing, executing, and assessing clinical research trials. This encompasses all stages of research: Initiation, Execution, Completion, and Administration. The position requires maintaining precise and thorough documentation of patient and study participant evaluation data. Responsibilities include coordinating strategies for participant recruitment, enrolling subjects, and managing data collection and reporting for institutionally sanctioned research studies. It is essential to ensure compliance with enrollment requirements and adherence to protocols 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 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 Job Qualifications
  • Preferred Licensure or other certifications: Clinical Research Certification or scheduled exam date.
  • Preferred Educational Requirements:
  • Preferred Experience:
  • Other:

Job Specific Knowledge, Skills, and Abilities
  • 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 current in knowledge and skills related to clinical research

Essential Tasks and Responsibilities
  • Recruit and screen potential study participants.
  • Develop and conduct educational sessions for patients and families regarding research participation related to diagnoses, treatments, and protocol specifications.
  • Perform subject evaluations, administer investigational products, and provide nursing support.
  • Collect study data, assist in creating data collection tools, study materials, and conduct 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 sponsors in a timely manner, e.g., 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letters, Financial Disclosures, etc., as necessary.

Ensure that staff resumes and licenses are current. Communicate with the Research Manager regarding study initiation needs. Identify necessary storage space for study products. 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 protocols and informed consents to subjects and obtain informed consents for subject participation. Oversee patient enrollment and follow-up.

Be available for study-related calls if needed. Maintain a 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, submitting documents to sponsors and/or IRB as applicable. Ensure that sponsor-required documents are completed, e.g., screening logs, Adverse Event (A/E) forms, memos to file, etc. Plan, organize, and participate in site initiation visits and continued monitoring visits. Review monitoring reports with the Research Manager. Ensure studies are completed on time and within budget. Communicate with external 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, patient care issues, and study design and/or conduct issues. Ensure that Adverse Events (AE) and Serious Adverse Events (SAE) procedures are followed accurately and in compliance with federal regulations and sponsor guidelines. Prepare study reports, e.g., modifications, amendments, Investigational New Drug (IND) reports, etc. Conduct yearly reviews of studies, completing yearly documents required by sponsors, IRB, and FDA. Review case report forms. Audit regulatory binders. Ensure timely and accurate communication with sponsors, research staff, and multiple functional areas within the institution, e.g., through regularly scheduled calls, team meetings, etc. Complete status reports and communicate with sponsors, research staff, Research Manager, and Investigator(s). Collaborate with key functional departments to coordinate project-related activities to meet project goals and milestones based on study design. Ensure that study data is submitted on time to data management for analysis. Ensure that the statistical analysis plan is complete, if applicable. Ensure that information is available for the completion of the final study report.

Communicate with the Research Manager regarding resource needs and issues, e.g., supplies, equipment, etc.
  • Study Completion: Complete study close-out procedures. Submit close-out documents to sponsors 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 that 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 a 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 about 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, 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.

Physical Demands
  • 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

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.

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