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VACANCY Position: Study Quality Assurance & Quality Control (QA/QC) Officer
Supervisor: Study Coordinator
Job Summary
The Study QA/QC Officer coordinates quality assurance and quality control measures in
protocol implementation; ensuring adherence to protocol requirements, Standard Operating
Procedures (SOPs) and Good Clinical Practice (GCP) principles.
protocol implementation; ensuring adherence to protocol requirements, Standard Operating
Procedures (SOPs) and Good Clinical Practice (GCP) principles.
Duties and Responsibilities:
1. Provide guidance to the study teams as regards protocol implementation.
1. Provide guidance to the study teams as regards protocol implementation.
2. Have in-depth understanding of the protocols and SOPs and ensuring the protocols and SOPs are followed by conducting audits
3. Participate in the maintenance of GCP auditing systems including quality planning,
process improvement, SOP development, and tracking and trending audit findings.
process improvement, SOP development, and tracking and trending audit findings.
4. Review the regulatory folder periodically.
5. Performing timely quality check on the informed consent forms, case report forms,
specimen collection and other study documents
specimen collection and other study documents
6. Conducting source data verification. to verify accuracy and consistency of data between the CRFs and source documents to ensure adequate and complete data collection.
7. Review and correction of Source Documents (SD) and Case Report Forms (CRF) before
data entry.
data entry.
8. Compile and present daily, weekly, monthly, quarterly and annual Quality Assurance
Areports as may be applicable.
Areports as may be applicable.
9. Review Data Management communications and resolve discrepancies and respond to data
queries.
queries.
10. Coordinate Quality Assurance review of clinical study reports. 11. Keep study staff informed of changes in clinical research guidelines and regulations and
directives.
directives.
12. Assist with site preparations for visits by external monitors and auditors where necessary
13. Assist the Study Coordinator in the conduct of research to ensure compliance with the
approved protocols.
approved protocols.
14. Actively reviewing the various components of the research process to assess adherence to
the protocol, policies, and to determine the accuracy of research records.
the protocol, policies, and to determine the accuracy of research records.
15. Comprehensive comparison of all components of documentation, such as the protocol,
source documents, and Case Repot Forms (CRFs) to assess compliance, agreement, and
validity/accuracy.
source documents, and Case Repot Forms (CRFs) to assess compliance, agreement, and
validity/accuracy.
16. Providing internal audits of study staff which include the accuracy and completeness of
the source documents and CRFs in accordance with the requirements of the protocol.
the source documents and CRFs in accordance with the requirements of the protocol.
17. Develop, direct and coordinate a Quality Assurance/ Quality Control (QAQC) program
for all the study sites
for all the study sites
18. Ensure patient confidentiality by ensuring patient CRFs are well handled and stored.
19. Respond to study queries within the timelines stipulated by the protocol and SOPs
20. Support field staff in establishment of work priorities related to data, schedules and goals.
21. Training staff on Research Ethics and Good Clinical Practice (GCP)
22. Perform other duties as may be assigned.
Required Qualifications and Experience:
1. Diploma/Bachelor’s Degree in Nursing, or Clinical Medicine and Surgery
2. Registration by the relevant professional body- Nursing C o u n c i l or Clinical Officers’ Council of Kenya.
3. Experience in Clinical Research and HIV related care and support.
4. Training in Research Ethics, including Human Subjects Protection and Quality Assurance /Quality Control
5. Experience in Research Quality Assurance /Quality Control would be preferred.
Skills & Competencies:
Skills & Competencies:
1. Effective oral and written communication skills
2. Basic computer application skills.
3. An understanding of principles of Good Clinical Practice (GCP)
4. Excellent interpersonal and organizational skills
5. Meticulous and with high degree of keenness; attention to detail and systematic approach to work.
6. Ability to prioritize on competing workloads a n d e v e n work for long hours.
7. Proven leadership skills, assertiveness, and ability to take initiative
Terms of Employment: 1 year renewable contract.
The first three months will be probation period. Applications be forwarded to: recruiting@hjfmri.org on or before 03 September 2021. Only shortlisted candidates will be contacted. HJFMRI is an equal opportunity employer.
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