Summary
Date Posted: Thursday, February 02, 2023 , Base Salary: Not Disclosed

JOB DETAILS:
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 following 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;


Education Requirement: No Requirements

Job Experience: No Requirements

Work Hours: 8

Job application procedure

Applications MUST include the following:
• Letter of Application (INDICATE VACANCY NUMBER)
• Current Curriculum Vitae with telephone number and e-mail address
• Contacts of three referees including telephone numbers and/or e-mail addresses
• Copies of Certificates.
• Contact telephone number

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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