What Clinical Research Coordination Jobs are in Kenya?

• Conduct site initiation, interim, and close-out monitoring visits according to study protocols and SOPs.
• Verify the accuracy, completeness, and consistency of source documentation and case report forms (CRFs).
• Ensure compliance with Good Clinical Practice (GCP) guidelines, FDA regulations, and other applicable regulatory requirements.
• Manage and resolve data queries in collaboration with site staff and data management teams.
• Train site personnel on study-specific procedures, protocols, and regulatory requirements.
• Oversee study drug accountability and ensure proper storage and handling.
• Identify and report adverse events (AEs) and serious adverse events (SAEs) according to protocol.
• Communicate effectively with investigators, site staff, study sponsors, and internal study teams.
• Prepare monitoring visit reports and follow up on action items in a timely manner.
• Contribute to the development and review of study-related documents, such as protocols and informed consent forms.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial management role.
• Thorough understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Experience in therapeutic areas such as oncology, cardiology, or infectious diseases is a plus.
• Excellent communication, interpersonal, and organizational skills.
• Proficiency in using electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Ability to travel to clinical sites as required (up to 50% travel may be expected).
• Strong attention to detail and ability to manage multiple priorities effectively.
• Ability to work independently and as part of a remote and on-site team.
• Valid driver's license and reliable transportation.

• Conduct site initiation, interim monitoring, and close-out visits in accordance with clinical trial protocols and Good Clinical Practices (GCP).
• Verify the accuracy, completeness, and integrity of clinical data collected at research sites.
• Ensure compliance with all applicable regulatory requirements, including FDA regulations and ICH guidelines.
• Manage relationships with investigators and site staff, providing training and support as needed.
• Monitor patient safety and report adverse events according to established procedures.
• Review and ensure proper documentation and filing of essential study documents (e.g., source documents, Case Report Forms).
• Communicate effectively with internal project teams, including project managers, data managers, and statisticians.
• Resolve site-specific issues and implement corrective actions to maintain trial progress and data quality.

• Bachelor's degree in a life science, nursing, or related field.
• Minimum of 3 years of experience as a Clinical Research Associate, with a proven ability to conduct monitoring visits.
• Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Experience in therapeutic areas such as oncology, cardiology, or infectious diseases is a plus.
• Excellent organizational and time management skills.
• Strong written and verbal communication skills.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to clinical sites as required by the study.

• Conduct pre-study, initiation, interim monitoring, and close-out visits at clinical trial sites to ensure adherence to protocol, GCP, and regulatory requirements.
• Verify the accuracy, completeness, and compliance of clinical trial data through source data verification (SDV).
• Ensure investigational product is managed correctly at the sites.
• Train site personnel on study-specific procedures and protocols.
• Manage communication and relationships with principal investigators and site staff.
• Identify, document, and resolve site issues and deviations in a timely manner.
• Prepare and present monitoring visit reports.
• Ensure site compliance with all applicable local and international regulations.
• Support audit readiness and participate in audits as needed.

• Bachelor's degree in a life science, nursing, or related field. A Master's degree or equivalent experience is a plus.
• Minimum of 3-5 years of experience as a Clinical Research Associate, with a strong understanding of clinical trial phases and processes.
• Proficiency in Good Clinical Practice (GCP) guidelines and relevant regulatory requirements (e.g., FDA, EMA).
• Demonstrated experience in performing site monitoring visits and conducting SDV.
• Excellent verbal and written communication skills, with the ability to communicate effectively with site staff and internal teams.
• Strong organizational and time-management skills, essential for managing a remote caseload.
• Ability to work independently with minimal supervision and manage travel arrangements efficiently (if applicable for occasional site visits, though the role is primarily remote).
• Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).

• Competitive base salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance plans.
• Generous paid time off, including vacation, sick leave, and holidays.
• Retirement savings plan with employer contributions.
• Home office stipend for setting up a productive remote workspace.
• Opportunities for continuous professional development and training.
• Flexible remote work schedule.
• Career growth opportunities within a leading clinical research organization.

• Conduct pre-study, initiation, routine monitoring, and close-out visits to clinical trial sites.
• Ensure compliance with study protocols, Standard Operating Procedures (SOPs), GCP, and applicable regulatory requirements.
• Verify the accuracy, completeness, and consistency of clinical data by reviewing source documents.
• Train and support site staff on study-specific procedures and requirements.
• Manage site relationships and facilitate effective communication between sponsors and sites.
• Oversee subject recruitment and retention efforts at assigned sites.
• Resolve data discrepancies and ensure timely resolution of site issues.
• Prepare and submit visit reports and other required documentation in a timely manner.
• Ensure the proper storage and handling of investigational products and study supplies.

• Bachelor's degree in a life science, nursing, pharmacy, or related field.
• Minimum of 3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role.
• Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Proven experience in conducting site monitoring visits and managing multiple clinical trial sites.
• Excellent interpersonal, communication, and organizational skills.
• Ability to work independently and manage time effectively.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel frequently to clinical trial sites.
• Strong problem-solving skills and attention to detail.

• Competitive salary and performance-based bonuses.
• Comprehensive medical, dental, and vision insurance plans.
• Paid time off and company holidays.
• Mileage reimbursement and travel expense coverage.
• Opportunities for professional development and certifications.
• Retirement savings plan.
• Flexible hybrid work arrangement.
• Collaborative and supportive team environment.

• Lead the development of clinical trial protocols, ensuring scientific rigor and alignment with regulatory requirements.
• Collaborate with investigators, study coordinators, and clinical operations teams to ensure effective trial execution.
• Oversee data analysis and interpretation, contributing to clinical study reports (CSRs) and scientific publications.
• Provide scientific and medical expertise throughout the clinical development lifecycle.
• Contribute to the preparation of regulatory documents, such as Investigational New Drug (IND) applications and New Drug Applications (NDAs).
• Stay informed about the latest scientific literature, clinical trial methodologies, and regulatory guidelines relevant to the therapeutic area.
• Represent the company at scientific meetings and interact with key opinion leaders.
• Participate in cross-functional team meetings, providing scientific insights and strategic input.
• Ensure compliance with all ethical and regulatory standards in clinical research.

• Ph.D., Pharm.D., M.D., or equivalent doctoral degree in a life science or medical field.
• Minimum of 5 years of experience in clinical research, with a focus on clinical trial design and conduct within the pharmaceutical industry or a related organization.
• Strong understanding of clinical pharmacology, experimental design, and statistical principles applied to clinical trials.
• Proven experience in authoring clinical protocols, investigator brochures, and clinical study reports.
• Knowledge of regulatory requirements (FDA, EMA) for drug development.
• Excellent scientific writing and presentation skills.
• Strong analytical and critical thinking abilities.
• Demonstrated ability to work independently and manage multiple projects effectively in a remote setting.
• Experience in rare disease research is a significant advantage.

Our client, a renowned Contract Research Organization (CRO) dedicated to advancing medical innovation, is seeking an experienced and highly diligent Senior Clinical Research Associate (CRA) to join their team. This is a field-based role, requiring significant travel, with primary responsibilities centered around site management and monitoring for clinical trials conducted within the **Kericho, Kericho, KE** region. You will play a vital role in ensuring the quality, integrity, and accuracy of data collected in clinical trials, as well as ensuring compliance with all applicable regulations and protocols. The ideal candidate has a strong understanding of clinical trial processes, excellent interpersonal skills, and a commitment to patient safety and data integrity. This is an excellent opportunity to contribute to life-changing research in a dynamic and supportive environment.

• Manage and monitor clinical trial sites in the **Kericho, Kericho, KE** area, ensuring adherence to protocol, GCP, and regulatory requirements.
• Perform site initiation visits, interim monitoring visits, and close-out visits according to study plan.
• Verify the accuracy, completeness, and consistency of source documents and case report forms (CRFs).
• Ensure proper informed consent process and patient safety throughout the trial.
• Train site staff on study protocols, procedures, and regulatory requirements.
• Maintain effective communication with investigators, site staff, and internal project teams.
• Track study progress, identify potential risks, and implement mitigation strategies.
• Ensure timely submission of study-related documents and data.
• Prepare visit reports and conduct follow-up actions as needed.
• Adhere to all company policies and standard operating procedures (SOPs).
  Requirements
  • Bachelor's degree in a life science, nursing, or a related field.
  • Minimum of 5 years of experience as a Clinical Research Associate, with a proven track record in site monitoring and management.
  • In-depth knowledge of Good Clinical Practice (GCP), ICH guidelines, and relevant local regulatory requirements.
  • Experience in therapeutic areas such as oncology, cardiology, or infectious diseases is highly desirable.
  • Excellent understanding of clinical trial processes from study start-up to close-out.
  • Strong organizational, time management, and problem-solving skills.
  • Outstanding verbal and written communication skills, with the ability to build rapport with study personnel.
  • Must possess a valid driver's license and a reliable vehicle for extensive travel within the **Kericho, Kericho, KE** region.
  • Ability to work independently and manage a geographically dispersed territory effectively.
  • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  Benefits

  Our client offers a competitive salary commensurate with experience and a comprehensive benefits package. This includes health, dental, and vision insurance, as well as life and disability coverage. A retirement savings plan is provided. Opportunities for professional development include ongoing training, certifications, and attendance at relevant industry conferences. Travel expenses and mileage will be reimbursed. Our client values work-life balance and provides generous paid time off. This role offers the chance to make a real impact on clinical research within the **Kericho, Kericho, KE** area and beyond.

• Design and develop clinical trial protocols, including study objectives, endpoints, and statistical analysis plans.
• Oversee the execution of clinical trials, ensuring compliance with regulatory requirements (e.g., ICH-GCP) and company standards.
• Collaborate with cross-functional teams, including data management, biostatistics, and medical affairs.
• Monitor trial progress, identify potential risks, and implement mitigation strategies.
• Contribute to the preparation of regulatory submissions (e.g., IND, NDA).
• Analyze and interpret clinical trial data, and contribute to study reports and publications.
• Manage relationships with external investigators, clinical sites, and vendors.
• Stay abreast of scientific literature, clinical trial methodologies, and regulatory guidelines.
• Mentor junior clinical research staff and contribute to team development.
• Effectively communicate study progress and key findings to stakeholders.

• Advanced degree (Master's or PhD) in a life science, health science, or related field.
• Minimum of 5 years of experience in clinical research and development within the pharmaceutical or biotechnology industry.
• Proven experience in designing and managing Phase I-IV clinical trials.
• Strong understanding of ICH-GCP guidelines and other relevant regulatory requirements.
• Excellent scientific and analytical skills, with the ability to interpret complex clinical data.
• Strong project management and organizational skills.
• Exceptional written and verbal communication skills.
• Demonstrated ability to work effectively independently and as part of a remote, multidisciplinary team.
• Experience with data analysis and reporting tools.
• A background in (Specific therapeutic area, e.g., oncology, immunology) is a plus.

• Highly competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance coverage.
• Generous paid time off and company holidays.
• Retirement savings plan with company match.
• Opportunities for professional development, including training and conference participation.
• Flexible working hours and a fully remote work environment.
• Access to innovative research and development opportunities.
• Company-provided laptop and home office setup assistance.
• Employee assistance program for well-being support.

• Lead the design and development of clinical trial protocols, including study objectives, endpoints, and methodologies.
• Oversee the execution of clinical trials, ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical guidelines.
• Manage and mentor a team of clinical research associates, coordinators, and other research staff.
• Analyze and interpret clinical trial data in collaboration with statisticians and data managers.
• Prepare comprehensive clinical study reports, regulatory submissions, and scientific publications.
• Liaise with investigators, site staff, and external stakeholders to ensure smooth trial operations.
• Contribute to the strategic planning and portfolio development of clinical research initiatives.
• Identify and evaluate new research opportunities and potential collaborations.

• Ph.D. or equivalent terminal degree in a relevant biomedical science, medicine, or pharmacy field.
• Extensive experience (typically 7+ years) in clinical research, with a proven track record in leading and managing clinical trials.
• Deep understanding of clinical trial methodologies, study design, statistical analysis, and regulatory affairs.
• Demonstrated experience in a leadership or supervisory role within a research setting in **Mombasa** or a comparable environment.
• Excellent project management, organizational, and problem-solving skills.
• Strong written and verbal communication skills, with the ability to effectively present complex scientific information.
• Proficiency in clinical trial management software and electronic data capture (EDC) systems.
• Ability to foster a collaborative and productive research environment.

• Interpret complex genetic and genomic data, including SNP arrays, whole exome sequencing (WES), and whole genome sequencing (WGS) data, in the context of clinical research studies.
• Provide genetic expertise and consultation to clinical investigators, study coordinators, and other research personnel.
• Contribute to the design and development of genetic components for clinical trial protocols.
• Identify genetic biomarkers and variants associated with disease risk, progression, and treatment response.
• Collaborate with bioinformaticians and statisticians to ensure the rigorous analysis and interpretation of genetic data.
• Prepare reports, presentations, and manuscripts detailing genetic findings for internal and external dissemination.
• Stay current with advancements in clinical genetics, genomics, and relevant disease areas.
• Ensure compliance with ethical guidelines, regulatory requirements, and data privacy standards in all genetic research activities.
• Assist in the development and implementation of genetic testing strategies for research purposes.

• M.D. or Ph.D. in Genetics, Medical Genetics, or a related life science field.
• Board certification or eligibility in Medical Genetics is highly desirable.
• Minimum of 6 years of experience in clinical genetics research or practice.
• Extensive experience with various genetic and genomic technologies and data analysis platforms.
• Strong understanding of human genetics, molecular biology, and disease mechanisms.
• Excellent analytical and problem-solving skills, with a keen eye for detail.
• Proven ability to communicate complex genetic concepts effectively to diverse audiences.
• Experience working independently and collaboratively in a remote research setting.
• Familiarity with clinical trial operations and regulatory requirements is a plus.