Summary
Date Posted: Wednesday, September 01, 2021 , Base Salary: Not Disclosed

JOB DETAILS:
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.

Duties and Responsibilities:
• Provide guidance to the study teams as regards protocol implementation.
• Have in-depth understanding of the protocols and SOPs and ensuring the protocols and
• SOPs are followed by conducting audits
• Participate in the maintenance of GCP auditing systems including quality planning, process improvement, SOP development, and tracking and trending audit findings.
• Review the regulatory folder periodically.
• Performing timely quality check on the informed consent forms, case report forms, specimen collection and other study documents
• Conducting source data verification. to verify accuracy and consistency of data between the CRFs and source documents to ensure adequate and complete data collection.
• Review and correction of Source Documents (SD) and Case Report Forms (CRF) before data entry. Compile and present daily, weekly, monthly, quarterly and annual Quality Assurance
• Areports as may be applicable.
• Review Data Management communications and resolve discrepancies and respond to data queries.
• Coordinate Quality Assurance review of clinical study reports.
• Keep study staff informed of changes in clinical research guidelines and regulations and directives.
• Assist with site preparations for visits by external monitors and auditors where necessary
• Assist the Study Coordinator in the conduct of research to ensure compliance with the approved protocols.
• Actively reviewing the various components of the research process to assess adherence to the protocol, policies, and to determine the accuracy of research records.
• 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.
• 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.
• Develop, direct and coordinate a Quality Assurance/ Quality Control (QAQC) program for all the study sites
• Ensure patient confidentiality by ensuring patient CRFs are well handled and stored.
• Respond to study queries within the timelines stipulated by the protocol and SOPs

• Support field staff in establishment of work priorities related to data, schedules and goals.
• Training staff on Research Ethics and Good Clinical Practice (GCP)
• Perform other duties as may be assigned.

Required Qualifications and Experience:
• Diploma/Bachelor’s Degree in Nursing, or Clinical Medicine and Surgery
• Registration by the relevant professional body- Nursing Council or Clinical Officers' Council of Kenya.
• Experience in Clinical Research and HIV related care and support.
• Training in Research Ethics, including Human Subjects Protection and Quality Assurance
• /Quality Control
• Experience in Research Quality Assurance /Quality Control would be preferred.

Skills & Competencies:
• Effective oral and written communication skills
• Basic computer application skills.
• An understanding of principles of Good Clinical Practice (GCP)
• Excellent interpersonal and organizational skills
• Meticulous and with high degree of keenness; attention to detail and systematic approach to work.
• Ability to prioritize on competing workloads a nd e ve n work for long hours.
• Proven leadership skills, assertiveness, and ability to take initiative
Terms of Employment: 1 year renewable contract. The first three months will be probation period. 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.

Duties and Responsibilities:
• Provide guidance to the study teams as regards protocol implementation.
• Have in-depth understanding of the protocols and SOPs and ensuring the protocols and
• SOPs are followed by conducting audits
• Participate in the maintenance of GCP auditing systems including quality planning, process improvement, SOP development, and tracking and trending audit findings.
• Review the regulatory folder periodically.
• Performing timely quality check on the informed consent forms, case report forms, specimen collection and other study documents
• Conducting source data verification. to verify accuracy and consistency of data between the CRFs and source documents to ensure adequate and complete data collection.
• Review and correction of Source Documents (SD) and Case Report Forms (CRF) before data entry. Compile and present daily, weekly, monthly, quarterly and annual Quality Assurance
• Areports as may be applicable.
• Review Data Management communications and resolve discrepancies and respond to data queries.
• Coordinate Quality Assurance review of clinical study reports.
• Keep study staff informed of changes in clinical research guidelines and regulations and directives.
• Assist with site preparations for visits by external monitors and auditors where necessary
• Assist the Study Coordinator in the conduct of research to ensure compliance with the approved protocols.
• Actively reviewing the various components of the research process to assess adherence to the protocol, policies, and to determine the accuracy of research records.
• 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.
• 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.
• Develop, direct and coordinate a Quality Assurance/ Quality Control (QAQC) program for all the study sites
• Ensure patient confidentiality by ensuring patient CRFs are well handled and stored.
• Respond to study queries within the timelines stipulated by the protocol and SOPs

• Support field staff in establishment of work priorities related to data, schedules and goals.
• Training staff on Research Ethics and Good Clinical Practice (GCP)
• Perform other duties as may be assigned.

Required Qualifications and Experience:
• Diploma/Bachelor’s Degree in Nursing, or Clinical Medicine and Surgery
• Registration by the relevant professional body- Nursing Council or Clinical Officers' Council of Kenya.
• Experience in Clinical Research and HIV related care and support.
• Training in Research Ethics, including Human Subjects Protection and Quality Assurance
• /Quality Control
• Experience in Research Quality Assurance /Quality Control would be preferred.

Skills & Competencies:
• Effective oral and written communication skills
• Basic computer application skills.
• An understanding of principles of Good Clinical Practice (GCP)
• Excellent interpersonal and organizational skills
• Meticulous and with high degree of keenness; attention to detail and systematic approach to work.
• Ability to prioritize on competing workloads a nd e ve n work for long hours.
• Proven leadership skills, assertiveness, and ability to take initiative
Terms of Employment: 1 year renewable contract. The first three months will be probation period.

Work Hours: 8

Experience in Months: 36

Level of Education: Bachelor Degree

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Job application procedure
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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