The University of North Carolina – Global Projects Zambia (UNC-GPZ) is conducting a study to exhaustively document the course and outcomes of labor, delivery, and the immediate postpartum period in settings where the occurrence of adverse birth outcomes is high. The Senior Research Nurse – QA/QC will be directly responsible for quality control of data collected on all study participating during the course of the study including from enrollment through discharge and follow-up, including but not limited to exam findings, medications administered, provider actions, and diagnoses.
MAJOR RESPONSIBILITIES: (include but are not limited to the following)
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Quality Assurance / Quality Control
- Collaborate with the Study Coordinator and study staff in all aspects of data collection and forms completion.
- Communicate to relevant clinic staff any missing, incomplete, or unclear data.
- Verify that all required study forms/data are complete, accurate, and processed in a timely fashion.
- Provide timely constructive feedback to study staff regarding forms completion and accuracy.
- Ensure the safe keeping of participant records at all times.
- Assist in preparing QC Tools and QC systems for the study.
Study Procedures
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- Supervise study staff in the completion of study activities. Conductstudy procedures as needed and adhere to procedural and international guidelines for research conduct at all times. Activities may include:
- Screening potential participants
- Determining participant eligibility prior to enrollment
- Obtaining informed consent
- Obtaining participant locator information
- Completing data collection forms
- Collecting specimens and performing point of care testing
- Reviewing medical records
- Identifying, documenting, and tracking adverse events
- Performing self quality checks (QC) in a timely manner
- Report to the study team as needed on accrual and retention targets and participant management.
- Ensure that study-related clinical information is communicated in a timely manner to research nurses and clinicians.
- Coordinate and collaborate closely with other study staff and laboratory to ensure accuracy and logic of data, and that data are collected according to study protocol.
- Assist in writing reports and preparing for monitoring visits and follow-up post visit to ensure required changes/targets are achieved.
- Maintain strict participant confidentiality and privacy at all times.
- Be accountable and responsible for study resources and supplies, such as data collection tools, participant files, study supplies, and facilities.
Research Administration
- Assist with procurement and maintenance of study equipment/supply inventory and storage as needed.
- Ensure study staff maintains good conduct and discipline towards participants, partners and families, community, UTH staff, and fellow study staff.
- Maintain facilities in good order including fire extinguishers, smoke detectors, generators, air conditioners and other items depending on location.
Communication
- Consult and report to supervisors as necessary on any issues related to data, and to the accurate and successful implementation of the study.
- Communicate with fellow staff members openly and honestly about study progress, issues, and/or problems that may arise.
- Provide feedback in a professional and supportive manner to develop collaborative, constructive solutions to any problems/issues.
- Actively participate in problem solving.
- Work collegially as part of the study team.
- Provide high quality service to participants by maintaining pleasant relationships at all times and attending to participants in a timely manner. Be responsive to enquiries from participants’ partners and family members as required.
- Report staff member concerns to the Study Coordinator as necessary.
- Collaborate with Community Educators on recruitment and retention. Serve as a liaison to the community and district staff as needed.
Personnel and Training
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- Liaise with the HR department regarding completion and submission of leave forms, performance appraisals and other required HR activities/documents.
- Assisting in coordination of staff meetings, daily schedules, etc.
- Train study staff on common data errors/problems and other implementation issues as needed to update/maintain competence of study staff.
- Complete all required study training, including routine Human Subjects Protection and Good Clinical Practices training, and regularly attend study meetings.
- Acquire and maintain an in-depth knowledge of the study protocol.
Other Activities
- Assist with study translations as requested.
- Attend workshops, conferences and other meetings as requested.
- Any other duties or responsibilities necessary for the successful implementation and functioning of the study.
SPECIAL SKILLS/COMPETENCES
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- Must be accurate and perform high quality work at all times.
- Must be organized and an independent worker with ability to work with minimum supervision
- Must have excellent, communication, problem solving, analytical, interpersonal and human relationship skills.
- Must be proficient in Microsoft programs
- Able to organize and schedule multiple work-related tasks efficiently
QUALIFICATIONS
- The job holder must have a minimum of a Registered or Enrolled Nursing Diploma (midwifery or paediatrics preferred) or recognized equivalent with at least 5 years of experience in research.
- Demonstrated experience working with computers and data
- Experience in QA/QC and research activities
- Company: UNC Global Projects
- Location: Zambia
- State: Lusaka
- Job type: Full-Time