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  • Posted: Nov 4, 2020
    Deadline: Dec 4, 2020
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    Synexus is a unique company that excels in the identification, recruitment and retention of patients for clinical trials, on behalf of a number of leading pharmaceutical, biotechnology and contract research organisations (CRO’s): Together for the future of health. Founded in 1992 Synexus operates a network of 27 dedicated research centres including t...
    Read more about this company


    Site Compliance Specialist

    The Role

    Do you have an audit/quality compliance background?. Do you want to work for a leading multinational organisation, renowned throughout the industry for its meteoric rise to success and dependability to deliver on global contracts across multiple therapeutic areas and phases?. Are you looking to play an integral role in the future of medicine across the globe? If so, this may be the opportunity for you!

    We are currently recruiting a Site Compliance Specialist for our clinical site in Stanza Bopape, Pretoria. This role will be responsible for oversight of data and quality control to the clinical trial process by ensuring all study documentation and source data is accurate and up to date; assist with the maintenance of the Investigator Site Files (ISF)as well as performing quality compliance review activities and answering any CRF queries, if necessary, in a timely manner.

    Key responsibilities for the Site Compliance Specialist are as follows:

    • Acts as a core operational compliance specialist on several studies to ensure the successful delivery of projects
    • Participates in the start-up, set-up and close out of projects, ensuring adherence to the client and company expectations.
    • Ensures accurate and timely entry of all data in the CRF from the source notes and track the flow of the CRF’s, queries and patient recruitment status and report out the flow of data, where applicable.
    • Maintains ISF and trackers as delegated.
    • Ensures patient visits are within visit windows, as per protocol, and reports deviations.
    • Assists with archiving procedures, if required.
    • Serves as a liaison with monitors and client representatives and completes preparations for monitoring visit duties and audits.
    • Ensures prompt response within agreed timeframes to data clarification requests.
    • Identifies quality issues (QI) and reports it as required, and support, trains and mentors junior staff.
    • Ensures Company Procedures and Site SOPs are adhered to and gives clarity and guidance to others in the implementation thereof.
    • Reviews informed consent forms for completion and escalates concerns to management.
    • Ensures adherence to rules and regulations of ICH, GCP and other regulatory and ethical guidelines as well as data protection regulations.
    • Reports any non-compliance of service level agreements.
    • Highlights auditor findings and proposes CAPA actions and root cause analyses.
    • Responsible for audit preparation and ensuring the audit readiness of site files.
    • Identifies trends in data queries.
    • Provides guidance on functional GCP, and other compliance and quality related topics, as required, to improve quality and expertise within the site.
    • Identifies quality compliance training needs of site staff and provides training, as required (i.e. data systems, ISF) and assists with induction of new site staff.

    To be considered for this exciting opportunity you will require the following skills and experience:

    • Professional knowledge of theory and techniques in the data and compliance field
    • A minimum of 3 years’ experience in clinical research industry
    • Comprehensive industry knowledge of quality compliance, GCP
    • Strong understanding of the audit process, including audit preparation and oversight, sponsor, internal audits (regulatory authority and FDA will be advantage), as well as CAPA reporting and basic root cause analyses
    • Experience with the preparation of and collation of regulatory documents for ethics submissions
    • Experience of HVTN/Network regulatory process and preparation of documents for submission will be an advantage
    • Strong multitasking and project management skills
    • Strong interpersonal, leadership, and consultative skills
    • Good working knowledge and understanding of Business English
    • Appropriate MS Office Skills
    • Strong medical terminology knowledge
    • Strong time management skills
    • Ability to work without direct supervision
    • Thorough attention to detail

    Interested? Great, please apply ASAP as we may close the advert earlier than the expiry date

    AES is an Affirmative Action and Equal Opportunity Employer.

    Closing Date: 04/12/2020

    Method of Application

    Interested and qualified? Go to Synexus Clinical Research Ltd on to apply

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