RV 517 Quality Assurance Officer Jobs at Henry Jackson Foundation Medical Research International (HJFMRI) February, 2019
Henry Jackson Foundation Medical Research International (HJFMRI) In Support of the U.S. Military HIV Research Program (MHRP)is an internatP)is an international non-governmental organization working in several countries providing care and treatment to people affected by HIV/AIDS and conducting research studies and has been actively involved in HIV and AIDS programming for over 30 years.
HJFMRI implements PEPFAR funded HIV prevention, care and treatment activities in the Southern Highlands, providing resources, personnel ans, personnel and services to the Zone. The program has expanded from supporting the Mbeya Zonal Referral Hospital in becoming a hub for anti-retroviral treatment in the Southern Highlands zone; to community support through decentralized services, with the overall objective of implementing research, clinical HIV, preventiol HIV, prevention, care and treatment services in Mbeya, Rukwa, Katavi, Ruvuma and Songwe regions in the zone.
In collaboration with the Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC) and community NGOs, HJFMRNGOs, HJFMRI has been leading a comprehensive HIV and AIDS care and support program in the Southern Highlands of Tanzania since 2004. The program, which is sub-contracting with Regional Health Management Teams (RHMTs) and 14 community outreach partners, extends to 25 district councils in the five regions. Collee regions. Collectively, the zone, which has one of the highest HIV prevalence rates in Tanzania, represents a catchment area with close to 6 million people (13% of the population of Tanzania mainland). Despite remarkable achievements made over the past ten years, the expansion of HIV care and treatment interventions remterventions remains critical both at the facility as well as the community level.
HJFMRI is seeking qualified candidates to fill the position below.
Job Title: RV 517 Quality Assurance Officer (1
Reports to: RV 517 Study Coordinator
The Henry Jackson Foundation Medical Research International (HJFMRI) funded through the Department of Defense under PEPFAR works to support HIV/AIDS Prevention, testing, care and treatment services in the regions of Mbeya, Rukwa, Ruvuma and Katavi in the Southern Highlands of Tanzania. As it implements these activities HJFMRI is evaluating the impact through PEPFAR Implementation Science Studies. With this in mind, HJFMRI seeks to fill the position of a Quality Assurance Officer for the RV 517 Study: Prevalence of, and factors associated with virologic suppression and drug resistance in HIV positive children and adolescents in Tanzania. The overall aim is to understand what patient-level and facility-level factors contribute to better virologic outcomes in children and adolescents
The candidate will work under the supervision of the RV 517 Study Coordinator to execute the RV 517 study. This will include carrying out field visits to conduct quality assurance assessments for the study as dictated by the protocol.
The candidate will be responsible for ensuring RV517 study processes are conducted in accordance with guidelines and regulations of Good Clinical Practices. The candidate will develop, perform, and manage quality assurance activities in RV517 study. This will require working closely with the RV 517 Research Study Principal Investigator, Research Assistants, Data Management Officer, Counsellors, Nurses and all other personnel involved in the study to ensure quality of data, laboratory and clinical activity.
Duties and Responsibilities:
- Create and maintain in-house quality assurance procedures, systems and practices in relation to RV 517 clinical, laboratory and data activities.
- Ensure that all processes contributing to the performance of the study are conducted in accordance with Good Clinical Practices.
- Manage and maintain RV 517 databases and perform/assess quality checks within the system.
- Prepare and assist in preparing annual and quality reports and for the study.
- Prepare the study staff and materials for internal and external audits as required. IS Check source documents for accuracy of RV 517 study data
- Report the status of the quality levels of staff, systems and routine activities on a monthly basis.
- Plan for and preside over improvement plans for the study.
- Evaluate quality events, incidents, queries, and complaints and document accordingly.
- Keep up to date with all related quality compliance issues as required.
- Compile and prepare materials for submission to regulatory agencies including serious /adverse event and deviation reporting as required by the protocol.
- Document internal regulatory processes.
- Ensure regulatory rules are communicated through study policies and procedures.
- Ensure that study audits are conducted as required.
- Communicate any critical compliance risks and non-conformances to the Study P.l and Study Coordinator immediately and document as such. Ensure that remedial actions are initiated as required.
- Assume a lead role in preparing, conducting, and responding to regulatory agencies after internal and external audits.
- Track and document all training required for the study and report as required if any training are missed.
- Work with Data management Officer and Study Coordinator to ensure study staff compliance with data integrity and security policies.
- A Bachelor of Science Degree in a clinical or laboratory science related field.
- Demonstrate a good understanding of clinical, data and laboratory Standard Operating Procedures Development and Utilization.
- Be conversant with Principles of Good Clinical and Laboratory Practice.
- Be able to comprehend Research Practices and Procedures, and ready to learn.
- Knowledge of English required.
- Excellent organizational skills
- Good coordination skills and ability to work in a team.
- Fluency in English
- High degree of commitment
- Willing to work independently in a multidisciplinary team.
- Demonstrates strong analytical, problem solving skills.
- Strong written and verbal communication skills.
- Detail oriented, good organizational traits.
- Self-motivated, with strong leadership abilities.
- Good computer skills; inclination to adopt technology to maximize efficiency.
Cover letters and resumes should be sent by mail through post/EMS/DHL/ or any reliable Courier to the Human Resources and Administration Manager, P.O. Box 6396, Mbeya or transmitted by email to; firstname.lastname@example.org
NOTE: to be considered, applicants must put the TITLE OF THE JOB in the SUBJECT LINE, hand delivery applications are not accepted. Deadline for submission of the application is February 21, 2019. Those who do not meet the minimum requirements as detailed above should not submit applications.
APPLY TO: email@example.com Before February 21, 2019.
HJFMRI is an equal opportunity employer;
women are highly encouraged to apply.