HJFMRI was organized as a nonprofit corporation to be operated exclusively for charitable, educational and scientific purposes. HJFMRI offers international support for programs advancing medical research and providing care, treatment and education. HJFMRI’s services include program administration, managing and conducting research trials and providing infrastructure development. Since 2001, HJFMRI has developed relationships, infrastructures and expertise to help clinicians and researchers accomplish their scientific goals wherever they may work. HJFMRI works in a range of countries, with a variety of domestic and international programs dedicated to improving health and advancing medical knowledge.
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 and even work for long hours.
- Proven leadership skills, assertiveness, and ability to take initiative
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