The site has 36 staff members under the leadership of the Principal Investigator and the Co- Investigator. All staff are trained in Good Clinical Practice and Human Subjects Protection.
Continuous staff training goes on with weekly CMEs.
The staff at the Thika research clinic is dedicated, committed and highly motivated. They have a passion and a drive to excel in all aspects of their work.
The site has a sound human resource policy that guides on hiring, motivation and performance appraisal processes.
The departments include;
The recruitment and retention department comprises of 4 team members who are involved in the recruitment and retention of study participants for the ongoing clinical trials. The main recruitment strategy for the current trials is referrals from health care facilities. Other major recruitment activities include community education, community mobilization and radio talk shows.
The clinic is comprised of counsellors and clinicians. The counsellors are well trained in psychosocial support for volunteer participants. In addition they ably consent participants into clinical trials after explaining all the details of the study in question.
The clinicians provide excellent care to participants enrolled in the clinical trials. Safety of trial participants is paramount. The clinicians identify and monitor adverse events timely and appropriately. The clinic department conducts all their activities in accordance to the laid out Standard Operating Procedures (SOPs).
The administration department is involved in operations, logistics, human resource and finance activities of the site. It is responsible for the day to day running of the site.
The department is comprised of two social scientists and a qualitative assistant. The team’s primary goal is to conduct qualitative research which involves data collection, transcription, coding and analysis. They are also involved in writing abstracts, manuscript development and dissemination of key findings. The team also has experience in using qualitative data analysis softwares such as Atlas.ti, Dedoose etc
Data and quality control/I.T Department;
The Data/I.T department is comprised of a team of 4 members, who have attained Bsc. Degrees in the fields of Mathematics (Statistics) and Information Technology. The team is tasked with the responsibility of ensuring that all data generated for ongoing studies adheres to set GCP and Human Subject guidelines, which has seen the department/site at large continue to generate high quality data essential for clinical trials. They also perform QA/QC procedures on data collection process employed at the facility. The office is equipped with safe lockable storage cabinets and a Data Fax System for faxing of case report forms. The team also has experience in design, using electronic data collection system such as InForm, RedCap etc.
Access to this room is restricted.
The pharmacy department is part of the larger clinical department and is run by two full time pharmacy technologists and a part time clinical pharmacist. The pharmacy is stocked with adequate ARVs and essentials drugs to treat ailments that can be managed on site. In addition the team offers counselling on medication use, storage, disposal and counselling on various contraception methods to couples and individuals.
As multi-trial site the department is responsible for various trial commodities such as study vaccines, investigation drugs e.g Truvada and devices e.g NuvaRing,MEMsCap,Self testing kits, Wise-pill. To ensure the credibility and potency of this commodities, the department is equipped with an air conditioner, a de-humidifier and a fridge. Room temperature and humidity are regularly monitored and recorded twice daily.
The site main laboratory is located at Kenyatta National Hospital in Nairobi. The laboratory has 7 staff members, who are IATA accredited and have GCLP training. The laboratory is enrolled in an external quality assurance program and continues to perform satisfactorily. The laboratory is outfitted with a BSL-2 LAF hood, two -80°C freezers, liquid nitrogen storage tanks, a centrifuge, shaker and rocker, a reagent refrigerator, an ELISA washer and reader, a hematology analyzer, chemistry analyzer, two bays of bench space, and two desktop computers with analytical software and a repository database. Workspace and specimen accessioning areas are proximate to the bench area. A dedicated courier delivers specimens from the clinic to the laboratory to ensure the chain of custody and appropriate storage and transport conditions.