About

I possess over 16 years of experience in the field of clinical research, including 2 years dedicated to monitoring within phase III clinical trials. Additionally, I have fulfilled roles as a study coordinator across various research projects. My primary career objective centers on actively contributing to the advancement of healthcare by overseeing clinical trials to ensure patient safety and the accuracy of data in clinical trials.

Experience

Josephine Andesia

Work experience
  • Conduct internal monitoring visits for protocol compliance.
  • Works together with other external monitors assigned to various studies during their site monitoring visits.
  • Assist in developing clinical trial procedures/protocol amendments and submitting these to the various regulatory departments.
  • Preparation of reports to the investigator and reporting any issues noted immediately to the sites.
  • Verifying consenting procedures ensure completeness and proper storage of the consent form to ensure confidentiality.
  • Perform checks for quality on the various documentation provided by sites.
  • Conduct drug accountability visits, inspect the storage area for study medication, and review drug inventory and subject accountability, records.
  • Prepare site regulatory documents, reviewing for completeness and accuracy for Initial submissions, continuing annual review and amendments to the various regulatory bodies.
  • Monitor investigator compliance for reporting Adverse Events (AE) and Serious Adverse Events (SAE’s)
  • Together with PI’s and study coordinators, review the monitoring reports and assist the site to implement follow-up or corrective action as needed.
  • Provides guidance and training to research staff to ensure compliance with rules and regulations associated with clinical research and to ensure that they are well-informed about the trial.

Josephine Andesia

Work experience
  • Liaise with various departments within to ensure smooth running of project activities.
  • Ensure that all the required supplies are available in all the sites as required including maintaining an inventory.
  • Budget management for all the assigned line items to ensure proper utilization.
  • Facilitate and oversee the planning and attend various weekly meetings with the study team, presenting in the investigator’s meetings and with the sponsor.
  • Prepare site regulatory documents, reviewing for completeness and accuracy for Initial submissions, continuing annual review and amendments to the various regulatory bodies.
  • Tracking of all the regulatory submissions to ensure timely submission of protocols and amendments.
  • Participating in protocol reviews, Standard Operating Procedures, designing and review of Informed consents, Manual of Operations, and Case Report Forms (CRFs)-qualitative and quantitative or any other study reporting tools.
  • Oversee study start-up activities including reporting and communicating with stakeholders regularly
  • Together with the data management team, support the development of a statistical analysis plan.
  • Development of the project work plan and monitoring plan.
  • Help to oversee the timely recruitment of study participants as per the accrual plan and update as required including any delays and the reason for the delays in recruitment.
  • Training of the research team members.
  • Travel to the field to supervise field activities.
  • Proactively identifies any challenges with the implementation of the study and develops corrective action plans.
  • Supervises sample collection storage and transportation.
  • Conducting Focus Group Discussions and semi-structured interviews for participants and ensuring proper translation and transcription before analysis
  • Verifying the accuracy and completeness of data.
  • Preparation of research technical reports, manuscripts, conference presentations, publications, and dissemination reports.
  • Communicating of any protocol deviation and violations to the relevant regulatory bodies.
  • Work with the Data Manager to ensure data systems are robust and well integrated with overall study aims, data query generation and resolution, and subsequent data analysis (qualitative and quantitative).
  • Complete study documentation and maintain study files as required.
  • Timely reporting of adverse events as per the protocol
  • Cost tracking of all project intervention costs to determine cost-effectiveness.

Josephine Andesia

Work experience
  • Assisted the Study Coordinator in monitoring the progress of research activities and ensuring the smooth and efficient day-to-day operation of research and data collection activities.
  • Participated in reviewing the accuracy, completeness, and timeliness of completed study-related records, case report forms, and other documents.
  • Ensured all staff are compliant with the protocol.
  • Worked closely with the Research Assistants to ensure that patient study files were properly filled, documented, and stored.
  • Assisted in administrative duties i.e. project requests
  • Trained the CHVs and staff, and ensured that all staff have completed human subjects training.
  • Supported data collection, entry, and management.
  • Facilitated focus group discussions and ensured timely transcription.

Josephine Andesia

Education
  • September, 2014 - September, 2018
  • Fulltime

Josephine Andesia

Education
  • January, 2009 - January, 2010
  • Fulltime

Josephine Andesia

Work experience
  • Conducted community entry activities into the participating sites.
  • Recruited and consented to all eligible study subjects.
  • Planned and conducted follow-up field visits to interview study participants.
  • Collected data through REDcap and MUzima application.
  • Conducted and transcribed focused group discussions and in-depth interviews.
  • Ensured safe custody of study records and tools for data collection.
  • Entered data into an electronic database.
  • Ensured timely and regular communication with the immediate supervisor
  • Participated in weekly and monthly meetings.
  • Documented any challenges, and lessons learned to ensure the success of the project

Josephine Andesia

Education
  • September, 2005 - December, 2006
  • Fulltime

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