Vacancy No. CVDC/013/01/23
Position summary
The successful candidate will be tasked with the organization and management of the study´s archive and all documentation linked to clinical trial in compliance with best practices and study specific procedures. The candidate will work under a multidisciplinary team of scientists, trial coordinators, study compliance officers, and clinicians, mainly reporting to the regulatory and monitoring team.
Job Specification
Quality control of documents including informed consent forms (ICFs), logs and others;
Reporting of protocol non-compliances related to ICFs;
Adherence to study SOPs related to archiving and handling of documentation;
Maintenance, organization and cleanliness of the archive;
Filing of all study documentation in an orderly manner according to the specific archive management procedures;
Ensure the proper conservation of study documentation, identifying risks to study documents and reporting these to line manager;
Scan and send documents to colleagues or monitors whenever necessary;
Manage and maintain the electronic archive of scanned documents;
Liaise with data management team wherever needed;
Accompany and provide support during monitoring visits;
Other tasks as directed by the regulatory and monitoring team.
Person Specification
Minimum of a Diploma in Archives, Records Management, Information Management, Information Science, Library Science or equivalent qualification from a recognized Institution;
Key Skills and Competencies
Team player with excellent interpersonal skills;
Solid organizational skills, including attention to detail and multitasking skills;
Excellent time management, prioritization and organizational skills;
Experience in health research is an added advantage; and
Experience follwoing GCP-ICH is an added advantage.
Desired Qualities
Ability to lift heavy boxes and standing for long hours; and
Ability to work under tight timelines and in a fast pace environment;
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Applications MUST include the following:Application letter should be addressed to The Deputy Director, CGMR (C),
P. O. Box 428– 80108 Kilifi.Application deadline is February 13, 2023
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