[Closing date: 28 February 2019]
Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for Neglected Diseases (www.dndi.org)
The DNDi Latin America office was opened in 2004. With the primary aim to support regional R&D activities for Chagas disease and leishmaniasis, the Latin American office also undertakes advocacy and communications activities to increase neglected diseases awareness in the region. It also leads capacity building projects through multi-country research platforms.
DNDi has a large portfolio of R&D activities covering 7 disease areas: human African trypanosomiasis, leishmaniasis, Chagas disease, filarial diseases, mycetoma, paediatric HIV, and hepatitis C. R&D projects are driven by patients’ medical needs for each disease area that in turn set strategy and scientific approaches.
DNDi does not have any research facilities and does not directly conduct research to develop its treatments. DNDi follows a virtual research model, whereby most research is outsourced with the R&D projects actively managed by DNDi personnel who are experienced in different aspects of pharmaceutical development.
DNDi proactively identifies research opportunities that have the highest potential to be translated into improved treatment options, then sources the research project into its portfolio, builds the full development plan, identifies and contracts the appropriate partners for each step in the development process, and manages the efficient advancement of the project throughout the pipeline.
Over half of the R&D staff is located in Geneva, working in close collaboration with disease-specific R&D teams operating in regional offices located in Africa, Asia, and South America.
Purpose of the position
The Senior CRA participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and close out visits. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by DNDi and partners. Works closely with the Clinical Trial Manager (CTM) and/or Clinical Manager to ensure all monitoring activities are conducted according to study requirements.
Specific job responsibilities
- Participate in the investigator recruitment process. Perform site evaluation visits of potential investigators. Evaluate the capability of the site to successfully manage and conduct the clinical study.
- Coordinate activities with the site in preparation for the initiation of the study. Obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
- Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities
- Train site staff on the EDC system and verifies site computer system
- Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Perform validation of source documentation as required by sponsor. Prepare monitoring reports and letters within the timelines as per SOPs
- Document accountability, stability, and storage conditions of clinical trial materials as required. Perform investigational product inventory. Ensure return of unused materials to designated location or verify destruction as required.
- Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries, blind reviews, and all data cleaning circuit.
- Assist on the preparation and review of protocols, ICFs, e-CRFs, study manuals, and other related technical documents, as required
- Serve as primary contact between DNDi and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as required
- Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items
- Responsible with the CTA of all study materials for the assigned studies: purchase, stock, follow up, among others.
- Assist with, and attends, Investigator Meetings for assigned studies
- Attend study-related, organizational, departmental, and external meetings, as required
- Conduct Field Evaluation Visits and field training of junior CRAs and other sr. CRAs and staff personnel as required
- Serve as mentor for junior CRAs and those new to the organization and/or study(s)
- Perform other duties, as requested
- Assist CTM and/or CM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions
- Assist CTM and/or CM in preparation and review of regulatory and importation dossiers
- Assist in identifying and generating changes in scope
Additional /specific/projects responsibilities
- Represent DNDi Regional Office in Bolivia, contributing to complementary dimensions of DNDi social mission, to enhance the regional footprint
- Contribution to the Chagas Platform and Chagas Access projects
Skills and attributes
- 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 to 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
R&D technical skills
- Medical and business knowledge
- Demonstrated ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team
- Advanced understanding of clinical development, knowledge and experience in international (FDA, EMEA, ICH) and local regulations
- Ability to multi-task and prioritize multiple high-priority projects, site questions, CRA questions, and clinical team inquiries while managing responsibilities and deadlines
- Minimum of 3-5 years of experience as a CRA
- Previous experience with clinical research in resource-limited settings is highly desired
- Bachelor’s degree in science or related fields
- An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is highly desired
- Native proficiency in Portuguese or Spanish
- Fluency in the other (Spanish or Portuguese) desirable
- Ability to communicate in English
- Good knowledge of Microsoft office
- S/he reports to the Clinical Trial Manager (CTM) and to the Clinical Manager (contributing manager)
- S/he will interact within transversal areas, mainly QA and PV teams, and with external partners and vendors as required
- Status: full time – permanent role – core consultancy
- Please submit your application using the online form
- Deadline for application: Accepting applications until 28 February 2019
- Only shortlisted candidates will be contacted