926 Clinical Research Associate Ii jobs in Kenya

• Conducts site initiation, routine monitoring, and close-out visits in compliance with ICH-GCP guidelines.
• Verifies the accuracy, completeness, and integrity of clinical trial data through source document verification.
• Ensures adherence to study protocols, standard operating procedures (SOPs), and regulatory requirements.
• Assesses site personnel qualifications and provides training on study procedures and data collection.
• Monitors patient safety and ensures all adverse events are reported according to protocol.
• Facilitates communication between study sites and the sponsor/CRO.
• Reviews and ensures timely submission of essential regulatory documents.
• Identifies site-specific issues and implements corrective action plans.
• Maintains accurate and up-to-date site visit reports and essential regulatory files.
• Contributes to the development and review of study-related documents.

• Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
• Minimum of 2-3 years of direct experience as a Clinical Research Associate or equivalent role.
• Thorough knowledge of ICH-GCP guidelines, FDA regulations, and other relevant regulatory requirements.
• Proven experience in performing site monitoring visits (remote and/or on-site).
• Strong understanding of medical terminology and clinical trial processes.
• Excellent written and verbal communication skills.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical trial sites as needed (for this hybrid role).
• Strong organizational and time-management skills, with the ability to prioritize tasks effectively.
• Problem-solving skills and a proactive approach to identifying and resolving issues.

• Analyze large and complex healthcare datasets, including patient demographics, clinical outcomes, claims data, and operational metrics.
• Develop and implement advanced analytical models to identify trends, patterns, and correlations in healthcare data.
• Design and create comprehensive reports, dashboards, and visualizations to present findings to key stakeholders, including clinicians, administrators, and executives.
• Collaborate with cross-functional teams to define data requirements and analytical objectives.
• Identify opportunities for improving healthcare quality, patient safety, and cost-effectiveness through data-driven insights.
• Develop predictive models for patient risk stratification, disease forecasting, and resource allocation.
• Ensure data accuracy, integrity, and compliance with healthcare regulations (e.g., HIPAA).
• Mentor junior data analysts and provide technical guidance.
• Stay current with the latest trends and technologies in healthcare analytics and data science.
• Translate business requirements into technical specifications for data extraction and analysis.
• Perform ad-hoc data analysis to support urgent business needs and research initiatives.
• Contribute to the development of data governance policies and best practices.
• Evaluate and recommend new analytical tools and methodologies.
• Communicate complex analytical findings in a clear and understandable manner to diverse audiences.

• Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Health Informatics, or a related quantitative field.
• Minimum of 5 years of experience in data analysis, with a significant focus on the healthcare industry.
• Proven experience with SQL for data extraction and manipulation from relational databases.
• Proficiency in statistical programming languages such as R or Python.
• Experience with data visualization tools (e.g., Tableau, Power BI, QlikView).
• Strong understanding of healthcare data sources, terminology, and common analytical challenges.
• Knowledge of healthcare regulations and data privacy standards (e.g., HIPAA).
• Excellent analytical, critical thinking, and problem-solving skills.
• Strong communication and presentation skills, with the ability to explain complex findings to non-technical audiences.
• Experience with predictive modeling and machine learning techniques is a plus.
• Ability to work effectively both independently and collaboratively in a hybrid team environment.
• Familiarity with electronic health records (EHR) systems is advantageous.

• Conduct remote research on aquatic ecosystems, focusing on biodiversity, water quality, and ecological health in and around the **Naivasha, Nakuru** area.
• Analyze complex ecological data sets using statistical software and interpret findings to inform conservation efforts.
• Develop and implement innovative conservation and management strategies for freshwater habitats, considering local environmental challenges.
• Collaborate with a global team of scientists, researchers, and stakeholders through virtual meetings and digital platforms.
• Prepare detailed scientific reports, research papers, and grant proposals.
• Contribute to public outreach and educational materials regarding aquatic conservation, utilizing digital communication channels.
• Monitor and evaluate the effectiveness of conservation interventions.
• Stay abreast of the latest advancements in aquatic biology, conservation science, and relevant technologies.
• Manage project timelines and deliverables in a remote work environment, ensuring effective communication and collaboration.
• Provide expert advice and guidance on aquatic resource management to relevant organizations and communities.

• Master's or Ph.D. in Aquatic Biology, Ecology, Environmental Science, or a related field.
• Proven experience (5+ years) in aquatic research and conservation, with a strong portfolio of published work.
• Proficiency in data analysis software (e.g., R, SPSS, MATLAB) and GIS mapping tools.
• Demonstrated ability to develop and implement successful conservation plans.
• Excellent written and verbal communication skills, with the ability to present complex scientific information clearly and concisely.
• Strong project management and organizational skills, with a proven ability to work independently and meet deadlines in a remote setting.
• Experience with remote sensing and drone technology for ecological monitoring is a plus.
• A passion for environmental conservation and a commitment to sustainable practices.
• Must be legally authorized to work in Kenya and able to work effectively in a remote, collaborative setting.
• Experience working with local communities and understanding of socio-ecological systems is advantageous.

Job Description
Job Title: Country Laboratory and Diagnostics Specialist
Job Profile: TECH31019 – Technical Officer III
Project:
The STRengthening Infectious disease DEtection Systems
(STRIDES) Activity
Reports to: STRIDES Country Team Leader
Compensation band: LL
About FHI 360:
FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, public health threats, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication, and social marketing - creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 70 countries and all U.S. states and territories.

Job Summary:
The Laboratory and Diagnostics Specialist will provide technical leadership and guidance to support the staff and projects for the anticipated USAID-funded Global Health Security project for the laboratory and diagnostic components in (country). S/He will lead and manage the development, implementation, and monitoring of strategic and technical initiatives to strengthen laboratory systems and diagnostic capacities. S/He will provide technical guidance around the issues, challenges, and strategies for building laboratory capacity in (country) and improving access to quality diagnostic testing related to project activities. S/He will work closely with country-level teams, including the project management team, project technical providers, and key stakeholders to ensure the provision of technical assistance to achieve effective, high-quality, and reliable laboratory services. S/he will lead the development of guidelines and policies for laboratory diagnostic network strengthening activities, provide technical thought leadership at the regional and country levels, and contribute to the development of project statements of work, work plan development, monitoring and evaluation systems, technical reporting, and other administrative elements of the project.

Accountabilities:
Technical Requirements:

• Provides overall technical leadership and strategic guidance to project staff for the laboratory and diagnostic services component of the project including coordination with other GHS technical areas (e.g., surveillance, data, etc.) to ensure synergy.
• Monitors and maintains project protocols, instruments, data sets, manuals, training materials, and reports related to diagnostic services and laboratory technical areas.
• Works in close collaboration with national, regional, and local counterparts to provide technical assistance required to fulfill project objectives and targets, primarily related to strengthening laboratory systems and diagnostic services.
• Leads or contributes to the development and writing of technical briefs, reports, or other necessary materials to facilitate research, best practices, policies, and procedures.
• Provides subject matter expertise to guide the implementation of laboratory and diagnostic network strengthening activities (e.g., specimen referral, quality assurance, laboratory information management system, training, etc.) across relevant GHS technical areas including antimicrobial resistance, zoonotic diseases, biosafety/biosecurity, diagnostic networks, and surveillance.
• Provides technical support in the scale-up and optimization of new diagnostic tools.
• Provides mentorship to support capacity building for project team members and subcontractors.
• Leads or assists with diagnostic network and laboratory capacity assessments including the reporting of findings and recommendations.
• Contributes to research initiatives to improve laboratory practices and diagnostic outcomes.

Project Design/Implementation:

• Promotes adopting and integrating new diagnostic technologies, tools, and methodologies based on the country's needs and priorities for project implementation.
• Works closely with country team project management, subcontractors, and stakeholders to align laboratory and diagnostic activities with overall project goals.
• Develops and monitors implementation of technical components of project work plans, along with associated budgets and resources, with a focus on project activities and sub-activities related laboratory and diagnostic-related components.
• Conducts analysis of project implementation to identify areas for improvement and proposes appropriate technical strategies to manage risks, overcome barriers, and advance project objectives.
• Monitors project activities, results, and deliverables and identifies and raises issues to management.

Client/Funder Support:

• Builds productive working relationships internally and externally by fostering collaboration with national and international organizations, government agencies, academia, and other relevant entities.
• Assists with the preparation and drafting of work plans, presentations, and reports for the USAID and other key stakeholders.
• Participate and represent the project in meetings and forums as required.

Operations Management (Finance, HR, etc.):

• Ensure project activities are on track with work plans, with technical expertise informing project implementation.
• Oversees project timelines and budgets. This includes monitoring of project activities to ensure they are on track with approved work plans, the spending on technical scope under broad supervision, and the collection of data for financial and technical reporting.
• Monitors project activities, results, and deliverables and regularly reports to management.
• Manage procurement as needed, coordinating with USAID and suppliers.

Project/Program Reporting:

• Prepares reports and papers summarizing project results and analysis of data sets including technical assessment findings.
• Establishes and maintains SOW and budget tracking systems.
• Creates technical content (e.g., summary reports, presentations, manuscripts) related to project activities, results, and outcomes.

Quality Assurance:

• Develops in-depth knowledge of quality standards through a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• Coordinates and directs activities to meet donor and regulatory requirements.
• Performs other duties as assigned.

Applied Knowledge & Skills:

• In-depth knowledge of laboratory and diagnostic-related concepts, practices, and procedures.
• Experience developing scopes of work with deliverables for subcontractors, consultants, etc.
• Broad knowledge of laboratory-related quality assurance and biosafety/biosecurity standards.
• Proficiency with database management software and online search tools required.
• Has sensitivity to cultural diversity and understanding of the political, contextual, and ethical issues in assigned areas.
• Articulate, professional, and able to communicate in a clear, positive manner with clients, partners, and staff.
• Excellent organizational and analytical skills.
• Excellent and demonstrated project management skills.
• Ability to influence and collaborate with others.
• Demonstrated proficiency with using Microsoft Office Suite required.
• Ability to analyze and interpret data, identify errors, and prepare reports.
• Ability to solve problems and implement corrective action as needed.
• Must be able to read, write, and speak fluent Spanish.
• Ideally able to read, write, and speak English

Problem Solving & Impact:

• Works on problems of moderate to complex scope that require a review of various factors.
• Exercises good judgment selecting methods and techniques to determine appropriate action.
• Identifies and raises issues with management.
• Networks with key internal and external personnel.

Supervision Given/Received:

• Serves as technical lead for diagnostics and may mentor other lower-level personnel.
• May supervise junior-level staff.
• Reports to Team Lead.

Education:

• Master's degree in microbiology or its international equivalent in biological sciences within a medical laboratory discipline or specialty. **

Experience:

• Typically requires 6+ years of relevant experience working with infectious disease diagnostics and/or in laboratory systems strengthening.
• Prior work experience with USAID-funded projects and familiarity with USAID regulations and reporting requirements is preferred.
• Extensive knowledge of laboratory practices, diagnostic techniques, quality assurance systems, and laboratory information management systems in human, veterinary, and/or environmental health sectors.
• Knowledge and understanding of infectious diseases, their transmission, and the application of methods and procedures to safely control infectious materials.
• Demonstrated ability to design, implement, and manage laboratory strengthening initiatives.
• Demonstrated experience in capacity-building activities such as training and mentoring laboratory personnel.
• Proven experience working with government agencies is highly desirable to support strategy development, implementation plans, and decision-making.
• Strong organizational, analytical, and problem-solving skills.
• Proficiency in English language is required.

Typical Physical Demands:

• Typical office environment.
• Ability to spend long hours looking at computer screens and doing repetitive work on a keyboard.
• Ability to sit or stand for extended periods of time.
• Ability to lift/move up to 5 lbs.

Technology to be Used:

• Personal Computer/Laptop, Microsoft applications (i.e., Office 365, SharePoint, Skype/Zoom/Teams), cell phone/mobile technology, and standard office equipment.

Travel Requirements:

• Up to 40% local and regional travel
• A bachelor's degree in medical laboratory sciences or its international equivalent with 8+ years of relevant experience will be considered as meeting requirements for this position.

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants' previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant's tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

FHI 360 will never ask you for your career site username or password, and we will never request money, goods or services during the application, recruitment or employment process. If you have questions or concerns about correspondence from us, please email
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

Please click here to continue searching FHI 360's Career Portal.

Job Title: Director, Clinical Laboratory Operations

Location: IAVI - Africa: Nairobi, Kenya, Cape Town, South Africa; OR Remote South Africa, considered

Reports to: Senior Director, Clinical Immunology and Lab Operations

IAVI is seeking a Director, Clinical Lab Operations to lead IAVI's lab operations in Africa. The Director will lead logistical, technical, and regulatory aspects of lab services for clinical trials, while driving lab quality, budget management, vendor oversight, often leveraging technology and data analysis optimizing performance. Director will lead strategy to support the development of vaccines and antibodies for HIV, TB, and emerging infectious diseases. Overseeing the implementation of good clinical lab practices (gCLP) across partner clinical research centers (CRCs) ensuring sustained and robust lab quality systems and operations.

Key Responsibilities

Quality Assurance:

• Development, implementation and monitoring of quality systems for both the internal IAVI Laboratory Operations unit as well as those of site labs selected, including:
• Ensuring readiness for technical audits
• Ensure laboratory operations meet regulatory standards and sponsor requirements
• Oversee preparation of sites for clinical trials and epidemiology studies.
• Oversee teams monitoring study progress at site laboratories for the duration of the study/trial.

Budget & Vendor Management:

• Development and management of operational budgets with budget managers and clinical teams based on study needs.
• Oversee the development of and implementation of associated integrated work plans and budgets, ensuring that the resources are allocated and deployed effectively.
• Review budgets and timelines ensuring integration with the overall clinical trials program.
• Identification and assessment of vendors to support Lab Operations.
• Development and review of scope of work, task orders and contracts for vendors.
• Management and oversight of procurement and vendor governance for a cost-effective and sustainable lab ecosystem.

Team Leadership:

• Building and mentoring a high-performing team, fostering leadership development, and implementing succession planning.
• Review and approval of all laboratory related documents for studies being implemented.
• Technology & Data:
• Leading the adoption of digital systems like LIMS (Laboratory Information Management Systems) and other platforms for enhanced efficiency, data analysis, and performance monitoring.

Regulatory Compliance:

• Ensuring all laboratory activities comply with Good Clinical Laboratory Practice (GCLP) and other accreditations (e.g. ISO and other relevant regulations and guidelines.
• Cross-Functional Collaboration:
• Serve in product development project teams as the laboratory lead.
• Serving as a key point of contact for CROs, clinical sites, and internal teams, influencing and leading clinical operations outcomes.
• Representing IAVI and its partners in various areas such as presenting project progress, achievements, and lessons learned to donors, and other key stakeholders in meetings and conferences.

Education and Experience:

• A Ph.D. in Immunology or related field and a minimum of 7 years of relevant independent research experience, either in a university or corporate setting, with experience working on clinical trials is required OR;
• A minimum of bachelor's degree in life sciences or related field and 10 years' experience in a safety laboratory will also be considered and clinical trials experience in developing countries is required.
• Experience working in a certified or accredited lab is required (e.g CLIA, ISO, CAP and GCLP).

Qualifications and Skills:

• Experience managing clinical laboratory research projects and staff to deliver high quality data to meet project goals and deadlines is required.
• Broad knowledge of clinical medicine, pathology disciplines, basic medical sciences, clinical laboratory sciences, laboratory operations, and quality management systems required.
• Experience in safety labs analysis and assay validation and verification, as well as assay development and optimization is required.
• Experience and understanding of ICH GCP, GCLP and other relevant regulatory requirements for clinical trials.
• Knowledge of and skills in informatics, data analysis, and business management highly preferred.
• Experience with vaccine clinical trials and assay development is highly preferred.
• Understanding of and experience with implementation of Good Clinical laboratory Practices in infectious disease clinical trials conduct is required.
• Strong organizational skills with proven experience in building strong, coherent and efficient teams.
• Solid reasoning and analytical skills.
• Experience in working in a decentralized system, and maintaining close working relationships with various departments, contractors, clinical centers and clinical and basic science laboratories.
• Excellent verbal and written communication skills.
• Proven ability to present programs to audiences ranging from high level scientists, clinical investigators and physicians, clinical trials execution teams and non-scientists is highly desirable.
• Experience working in a multicultural environment is required.
• Willingness to travel at least 20-25% of the time to IAVI regional and head offices required.
• Passion for the IAVI Mission.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases.

IAVI CORE VALUES:

• Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
• Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up
• Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect
• Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference

Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

IAVI IS AN EQUAL OPPORTUNITY EMPLOYER actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues' experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI's Global Diversity and Inclusion Committee.

Compensation And Benefits Information:

Salary is paid in local currency, and is commensurate and competitive with the local labor market. Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits including: generous retirement savings plan employer contributions; competitive health, dental and vision insurance plans; competitive paid time off policy; potential for annual bonuses based on performance; and other benefits. More information can be found on IAVI's career page.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the
Know Your Rights
notice from the Department of Labor.

• Collect, clean, and validate clinical trial data from various sources.
• Perform statistical analysis on trial data to identify trends, patterns, and significant findings.
• Develop and maintain databases and data management systems.
• Generate comprehensive reports and visualizations of data analysis results.
• Collaborate with clinical research associates, statisticians, and medical writers.
• Ensure data integrity and compliance with regulatory guidelines (e.g., ICH GCP).
• Assist in the design of clinical trial databases and data collection instruments.
• Identify data discrepancies and implement corrective actions.
• Stay updated on pharmaceutical research methodologies and data analysis tools.
• Contribute to the interpretation of study results and the preparation of regulatory documentation.

• Proven experience as a Data Analyst, preferably within the pharmaceutical or healthcare industry.
• Strong understanding of clinical trial processes and data management.
• Proficiency in statistical software packages such as SAS, R, or SPSS.
• Experience with database management systems (e.g., SQL).
• Excellent analytical, critical thinking, and problem-solving skills.
• Detail-oriented with a high degree of accuracy.
• Effective communication and collaboration skills for remote teamwork.
• Bachelor's degree in Statistics, Mathematics, Computer Science, Pharmacy, or a related scientific field.
• Experience with data visualization tools (e.g., Tableau, Power BI) is a plus.
• Minimum of 3 years of relevant experience in data analysis.