CLINICAL RESEARCH COORDINATOR
Posts: 1Ifakara Health Institute • Healthcare and Pharmaceutical
Job Description
Institute Overview
- Ifakara Health Institute (IHI) is a leading research organization in Africa with a strong track record in developing, testing and validating innovations for health. Driven by a core strategic mandate for research, training and services, the Institute's work now spans a wide spectrum, covering biomedical and ecological sciences, intervention studies, health-systems research, service delivery and policy translation.
Position Summary - Ifakara Health Institute is seeking a qualified Clinical Research Coordinator who will be stationed at Bagamoyo Office, reporting to the Head of Facility. The Clinical Research Coordinator, will be responsible for overseeing clinical trials or studies to test the effectiveness of biotechnology. The other duties includes sorting through applications and choosing qualified candidates, monitoring the health of each participant throughout the trial and compiling a report to summarize the success or failure of a particular drug, technology or medical procedure. This is an internal advert, internal applicants are encouraged to apply this role.
Requirements
- Strong knowledge of GCP, quality-management systems and clinical-trial operations.
- Competence in staffing control, training management and competence assessment.
- Proficiency in controlled document and procedure management.
- Competence in process QC, deviations, root-cause analysis, CAPA and change control.
- Strong audit, inspection and oversight-visit readiness skills.
- Ability to coordinate trial teams and institutional support departments.
- Ability to monitor compliance, track actions and escalate unresolved risks.
- Strong organizational, documentation and records-management skills.
- High attention to detail, independence, accountability and problem-solving ability.
- Relevant degree or professional qualification in health sciences, clinical research associate, clinical medicine, biomedical sciences, preferable with certificate as CRA or a related field.
- Current GCP training.
- Substantial clinical-trial coordination or clinical-research management experience.
- Demonstrated competence in staffing controls, training and competence systems, SOP lifecycle management, document governance and embedded QC.
- Demonstrated competence in deviations, root-cause analysis, CAPA and change control.
- Experienced in supervising or supporting Clinical Trial Coordinators.
- Experienced in coordinating multidisciplinary institutional departments and technical units supporting clinical research.
- Experienced in coordinating readiness for sponsor, regulatory, ethics and internal audits, inspections or oversight visits.
- Strong communication (Swahili and English) and stakeholder-management skills.
Disclaimer!
Ifakara Health Institute does not charge any fee at any stage of the recruitment process. Please disregard written or oral request for a job offer or an interview that you believe is or might be fraudulent or suspicious.
Key Responsibilities
- Operates the BCTF staffing-control, training, competence, controlled procedure and embedded-QC systems.
- Functionally supervises and supports trial-specific Clinical Trial Coordinators in applying BCTF systems, documentation and process requirements.
- Coordinates deviations, root-cause analysis, CAPA, change control and implementation of approved improvements.
- Serves as the primary operational support to the Head of BCTF for facility-wide and trial-specific audits, inspections and oversight visits.
- Coordinates readiness, documentation, responsible personnel, responses and follow-up actions.
- Coordinates BCTF interfaces with RQA and relevant IHI technical and administrative departments.
- Tracks agreed actions and escalated unresolved staffing, training, process, documentation or compliance deficiencies to the Head of BCTF.
- Verify with trial specific coordinators on
o Each trial's staffing, training, delegation, controlled-document, process-QC and institutional-support requirements.
o Required personnel, procedures, records and quality controls are ready before activation.
o Coordinates trial-specific Clinical Trial Coordinators and relevant BCTF and IHI technical leads during trial set-up, conduct, close-out and inspection readiness.
o Reassesses readiness following material protocol, staffing, process, system or risk changes.
About Ifakara Health Institute
Ifakara Health Institute (IHI) – or simply Ifakara - is a leading health research organization in Africa, with a strong track record of developing, testing and validating innovations for health. We are driven by core strategic mandate for research, training and services. Ifakara encompasses a broad range of scientific disciplines, spanning from basic biomedical and ecological sciences to clinical trials, health systems research, policy translation, and health program implementation.
Ifakara work is organized in three research departments, six research units and seven technical support units. The research departments are: Environmental Health & Ecological Sciences (EHES), Interventions & Clinical Trials (ICT), and Health Systems, Impact Evaluation & Policy (HSIEP).
The research units are: Grants and Contracts, Training & Capacity Building, Laboratories, Data Systems and Platforms, Vector Control Product Testing, and Chronic Diseases Clinics. The technical units, which are supporting research (our primary activity) are: Internal Audit, Knowledge Management and Communications, Finance Management, Human Resources Management, Supply Chain Management, Branch Management and Information & Communication Technology. We have three major offices in Tanzania (Ifakara, Bagamoyo & Dar es Salaam).
Vision
A healthy and empowered population with access to evidence-based health services and solutions
Mission
To be a centre of excellence that informs health policies and delivery of quality services collaboratively through research, innovation, capacity strengthening and program implementation