Drugs For Neglected Diseases Initiative (DNDi) – Clinical Research Associate (Nairobi).

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Established in 2003, the Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization that develops new, improved, and affordable medicines for deadly neglected diseases that afflict millions of the world’s poorest people.

DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, hepatitis C, and ANTICOV. Since its inception, DNDi has developed eight new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, and paediatric HIV with several new drug candidates in the R&D pipeline including two for sleeping sickness. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.

DNDi Africa was established in 2003 in Nairobi to ensure connection with our founding partner KEMRI and support clinical development programmes. This DNDi regional office conducts R&D projects in the Eastern Africa region (especially Kenya, Uganda, Sudan, Ethiopia, and Tanzania), including clinical activities and data management for clinical trials for treatments for leishmaniasis, paediatric HIV, mycetoma, and others. It also leads capacity strengthening initiatives through multi-country research platforms with the objective to ensure sustainable R&D capacities for DNDi projects. The team has grown to approximately 35 people today. As part of the global strategy, DNDi is further empowering its regional teams to ensure a coherent regional development across disease areas and activities, while reinforcing coherence among disease clusters.

Purpose of the position

The Clinical Research Associate is responsible for the set-up and follow-up of clinical trials in trial sites according to DNDi SOPs, applicable regulation, Good Clinical Practice, ICH guidelines, and in compliance with overall local, regional, and international regulatory obligations associated with the study. S/he participates in clinical trials and gets reliable clinical data (clinical trial set-up and clinical trial monitoring).

Specific job responsibilities

  • Conducts the site Initiation visit at the trial site.

  • Ensures that the trial site is ready to safely and properly conducts the clinical trials.

  • Reviews the ICF (the master and/or local language version as appropriate and any updates).

  • Initiate preliminary contact with the site investigator.

  • Set-up and conduct the Pre-study visit.

  • Writes the Pre-study visit report.

  • 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).

  • Conducts 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.

  • Contributes to and reviews the Monitoring Plan.

  • Performs activities as per the Monitoring Plan.

  • Responsible for the initial set-up of the ISF.

  • S/he is responsible for the IMP accountability at site.

  • Regularly reviews the ISF during the monitoring visits to ensure it is up to date and that the essential documents for the centers s/he oversees are appropriately recorded and filled in the investigator site file.

  • Provides support to the HDCP/Head 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 CTM and PV function, including on all local regulations and guidances (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 CTM 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 CTM (or delegate) for filing in TMF.

  • Responsible for monitoring the clinical trial sites and providing support to the HDCP and CTM in clinical trial management and all local/regional aspects (including overall regulatory intelligence and compliance).

  • 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 Trial 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 CTM authorization.

  • For IP returns, organizes shipment to the appropriate recipient.

  • For IP destroyed on site, requests a certificate of destruction.

Reporting line

  • S/he reports to the Clinical Project Manager

  • Close working relationship with the Head of Regional Clinical Operations, relevant members of the DNDi African regional office, Nairobi and DNDi global disease teams.

Experience

  • Minimum 3 years’ relevant experience with graduate degree, at least one year with postgraduate degree.

  • Proven ability to work effectively in a team environment and matrix structure.

  • Experience of working in public and private sector is highly desirable.

Skills and attributes

  • Very good knowledge of drug discovery/development.

  • Very good knowledge of clinical research development.

  • Very good knowledge of regulatory (GCP, GLP, and GMP).

  • Very good knowledge of eisease/academia knowledge.

  • 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 small projects if delegated by upper levels with supervision.

  • Ability to supervise an Intern or Apprentice.

Education

  • Graduate or postgraduate degree in relevant field.

Other requirements

  • Travel up to 50%

To apply

  • Please submit your application using the online form

  • Deadline for application: Accepting applications until 18 April 2021

  • Only shortlisted candidates will be contacted

  • Application submission for this position may close early if we have enough suitable applicants

https://dndi.org/work-with-us/2021/jobs/clinical-research-associate/

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Drugs for Neglected Diseases initiative - DNDi

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