Senior Clinical Research Associate

Job Locations KE-Nairobi
Job ID
2025-1202

About the Department

The R&D organisation drives therapeutic innovation from the lab bench to the patient bedsideIt develops DNDi’s portfolio of drug candidates from the onset (with the design of target product profiles) to the end point (enabling patients’ access to the new treatments). With members located in various DNDi offices worldwide, R&D teams are key enablers of DNDi’s virtual research model which relies on collaborative partnerships with industry and science partners worldwide, fully inclusive of LMICs clinicians and researchers. Projects are run by project leaders and team members regrouping needed expertise from all DNDi functions, beyond R&D. 

 

The R&D organisation include three clusters of Diseases expert teams: NTD/Mycetoma and Leishmaniasis, NTD/Chagas-Filarial-HAT and Viral DiseasesIntegrated Clinical Development Sciences (Drug Safety & Pharmacovigilance, Clinical Quality Assurance and Translational Sciences), Regulatory Sciences, Global Clinical Operations, R&D Portfolio and Planning, Discovery and Pharmaceutical Development teams complement the R&D expertise. Projects review, science and strategy is managed by the Scientific Internal Review Committee (SIRC); The R&D Coordination team lead the R&D organisation for all other topics  

About the Office

 

Counting the Kenya Medical Research Institute as a founding partner and numerous collaborations with science and access leaders in the broader East African region, DNDi established itself in 2003 in Nairobi. An integral part of DNDi’s global network, DNDi Eastern Africa nurtures R&D and access partnerships across East Africa and beyond, while contributing to DNDi's global strategy. It hosts key global functions such as global clinical operations, communications, policy advocacy and operations. It leads regional networks and initiatives in R&D and access such as the Leishmaniasis East Africa Platform, and is also home to DNDi’s Data Centre, processing and leading the statistical analysis of clinical trials data for DNDi and a growing cadre of African global health and science groups. 

Overview

The Senior Clinical Research Associate is responsible for the set-up and follow-up of a range of clinical trials / observational studies in sites according to DNDi’s SOPs, applicable regulation and Good Clinical Practice, other ICH Guidelines and in compliance with overall local, regional and international regulatory obligations associated with the study/ies conducted. Where applicable, to ensure the safety of the patients participating in clinical trials and get reliable clinical data. (Clinical trial set-up and clinical trial monitoring). The incumbent acts as lead CRA, managing a team of CRAs who are monitoring the studies.

Responsibilities

  • Initiate preliminary contact with the site investigator  
  • Responsible to set-up and coordinate the pre-study visits, write the Pre-study visit report and conduct the site Initiation visit at the trial site with the support of the CRAs  
  • Writes the Pre-study visit report 
  • Conducts the site Initiation visit at the trial site  
  • Ensures that the trial site safely and properly conducts the clinical trials. 
  • Reviews the ICF (the master and/or local language version as appropriate and any updates) 
  • Conducts the Site Monitoring Visits at the trial sites 
  • Verifies the validity, accuracy, consistency and quality of the data in Case Report Forms (CRFs) or data collection forms (e.g., data/forms sent to DNDi Pharmacovigilance) against source documentation. 
  • Checks compliance of the clinical trial conduct according to the protocol, GCP and the applicable regulations. 
  • Reviews the investigator Site File (ISF) for completeness 
  • Ensures appropriate test article storage, expiry date, dispensing, and accountability, if applicable. 
  • Verifies proper filing of any Safety expedited reporting or safety /clinical periodic reporting to Independent Ethics Committees (IECs)/institutional Review Board (IRB) / Regulatory Authorities (RAs)/other institutions (if applicable), 
  • Reviews safety reporting requirements and compliance (including tracking) 
  • Conduct the site close-out visit in the clinical sites. 
  • Submits the site close-out visit reports to the Clinical project Manager for review and approval 
  • Contribute to and review the Monitoring Plan.
  • Perform activities as per the Monitoring Plan.
  • Responsible for the initial set-up of the ISF. 
  • Regularly reviews the ISF during the monitoring visits to ensure it is up to date and that the essential documents for the centers overseed are appropriately recorded and filled in the investigator site file 
  • Provides support to the Head Diseases/TS with regards to local/regional safety regulatory intelligence. 
  • Provides in a timely manner necessary information to the PV function to develop the SMP. This includes providing necessary information to ensure SMP readiness prior to study initiation in each country, to the CPM and PV function, including on all local regulations and guidance’s (together, if necessary, with translation into English and interpretation). This includes seeking validation of interpretation of implementation modalities with regulatory bodies (RAs/ECs/other bodies), if necessary. 
  • Provides support to the CPM to track compliance with local safety reporting requirements in their region/country; this includes tracking submission dates and documenting submission (collecting proof of submission/notification) and sharing these documents with PV function and CPM (or delegate) for filing in TMF. 
  • Ensures the appropriate safety management at trial sites as defined in the protocol, monitoring plan and medical monitoring plan (if any) in compliance with the trial-specify Safety Management Plan. This includes source data verification, support to sites in completing trial-specify documents sent to PV and CRF data/queries, consistency check between documents sent to PV and CRF and request for correction, as necessary. 
  • Verifies that any deviations are properly documented.
  • Alerts the Clinical Project Manager in a timely manner in case of any issue and documents any findings in the monitoring reports.
  • During monitoring visits: Check that equipment is properly used and maintained, check that stock of consumables has not reach the alert threshold, check that expired consumables are put in quarantine or destroyed according to CPM authorization. 
  • For IP returns, organizes shipment to the appropriate recipient.
  • For IP destroyed on site, requests a certificate of destruction.

Reporting line & Interactions

  • Senior Clinical Research Associate reports to Senior Clinical Project Manager

Qualifications

  • Minimum 6 years’ relevant experience in which at least 3 years at Officer level or equivalent
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in public and private sector is highly desirable
  • Graduate or post graduate degree

Experience and Education

  • Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
  • Clear and systematic thinking that demonstrates good judgment and problem solving competencies
  • Very Good communication skills in multicultural, multi-lingual environments
  • Ability to work effectively as part of a multicultural team
  • Well organized and structured
  • Very good analytical skills
  • Ability to contribute to the project delivery under minimum supervision
  • Ability to manage middle sized projects with budget management under supervision
  • Provide specialist services to operational line or project team
  • Ability solve non-routine problems on a case by case/project basis
  • Has certain autonomy for taking actions and decisions
  • Ability to interact with external stakeholders
  • Ability to be the focal point/manager for consultants
  • Ability to supervise at a smaller level

Other requirements

  • Fluency in English
  • Proficiency in local languages desirable
  • Good knowledge of Microsoft Suite

DEI Statement

DNDi is committed to building a diverse, equitable and truly inclusive organisation. Our success and global reach are dependent upon our ability to encourage diversity and draw on the skills, understanding and experience of all our people. We particularly welcome applications from those who are underrepresented in at DNDi and across the sector, especially women, and including, but not limited to, black and minority ethnic candidates, and those with other protected characteristic.

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