Caroline Makokha

• Performed and documented quality control checks to maintain compliance with company initiatives.
• Worked with governance committees (IRBs, KPPB and NACOSTI to make and evaluate plans.
• Recommended improvements to processes.
• Prepared and maintained document inventory for core dossier preparation.
• Consolidated global information relevant to clinical trials and monitored submissions and approvals status.
• Devised and deployed techniques for obtaining earliest possible approval for each research study/clinical trial.
• Managed applications, tracked study approval progress and handled all responses to regulatory inquiries.
• Directed documentation efforts to comply with domestic and international regulations and standards.
• Managed all regulatory needs for protocols such as initial submissions ,amendments and deviations/adverse events.
• Skilled at working independently and collaboratively in a team environment.
• Assisted with regulatory product compliance initiatives such as; preparation of IRB submissions, protocol development, training of personnel on regulatory requirements

Critical review of IRB submissions including initial review, amendments, adverse events, notifications, annual reports etc.,

Providing recommendations for research conduct based on ICH-GCP principles

Conduct research site monitoring/ inspection

Provided overall coordination of integrated disease surveillance activities,

Contributed to the design of studies and research protocol development

Developed study standard operation procedure (SOP) and study monitoring documents

Established collaborations with stakeholders

Spearheaded study IRB approval processes

Ensured compliance with regulatory requirements for research conduct

Planned for and facilitated protocol, SOP, ICH-GCP trainings for study personnel.

Gathered and organized materials to support operations, collaborating between field teams, laboratory and investigators

Entered data in electronic databases, generated reports, and produced tracking documents.

Provided data quality checks

Analyzed data using STATA and Excel to generate reports

Prepared and presented abstracts and posters for international conferences

Developed manuscripts for publications

Planned for and hosted study sensitization meetings, Disseminated study findings to different audiences and stakeholders.

Evaluated operational practices and identified improvement opportunities to develop revisions for systems and procedures.

Participated in workshops and in-service meetings to enhance personal growth and professional development.

Implemented cost reductions processes and developed reporting procedures to maintain administrative workflow.

Set priorities and problem-solved workflow issues to maintain rapport with study participants, personnel and investigators

Authored manuscripts published in peer reviewed journals