Study Description
The KEN SHE Study is a prospective, blinded randomized study that will test the efficacy of single- dose bivalent and nonavalent HPV vaccination as a catch-up strategy.
KMR /6 (K) Vacancy No. FN-007-02-2020
Reports to: Study Coordinator
Duration: 1 Year Renewable Contract as per KEMRI Scheme of Service. The first 3 months is a probation period
Duties and Responsibilities
Overseeing daily data activities
Oversee and mentor data clerks’ duties
Conduct training of all data clerks and relevant staff on data specific items, study protocol, SOPs and documents, equipment use
Creating and maintaining all study database
Updating and overseeing databases updates
Generating study summaries and reports as required
Arranging screening, enrolment and follow up files for daily schedules
Performing QA/QC of Case report forms (CRFs) and name chart, ensures competency at all QC levels
Printing CRFs and arranging them in study binders as needed.
Communicates with CC on behalf of data in relation to QC, supplies, CRFs updates and changes in CRFs.
Ensures Label printing and delivery to the clinic team
Spear heads analysis and resolution of DFNet queries
Organizes eligibility meetings, tracks the screen/enrollment participant status records and provides daily reports in liaison with study Doctor. Develops all data related SOPs
Assist staff in data analysis e.g. abstract writing
Ensures data printers and data fax machines are maintained and stored well. Maintain data supplies inventory Manage study data
Tracking of all study documents, data and storage
Ensures archival procedures of all study data, hard and soft is secured and stored well Ensures confidentiality and safe storage of all participant identifying materials like link logs are kept confidentially.
Gives QA/QC monthly and weekly reports Provide weekly site data reports
Required Qualifications
Minimum of an Undergraduate Degree in Statistics/ Applied Statistics/Biostatistics/Computer science
Conversant with statistical packages i.e Stata, SPSS , R, SAS.
Conversant with data management databases i.e MS access, Excel SQL or Visual basics.
Basic IT skills i.e. software installations, printer installations and trouble shootings.
Having experience with data fax transmission machine is an added advantage.
At least two (2) years data management and/or related work experience in a clinical research setting.
Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
Working knowledge of Clinical database applications such as EDC and CTMS and data management data bases such as MS access, Excel SQL or Visual basics
Desirable Qualities
Leadership skills to promote creativity and innovation.
Excellent verbal and written skills, good organizational, interpersonal, and team skills.
Applicable knowledge working with other clinical databases eg SAS, etc .
Experience with working on Phase I- IV study trials within a clinical set up.
Organizational and time management skills.
Must have strong written and verbal communication skills, project management skills, computer skills, and database skills.
Ability to lead a team of workers
