Xcene Research is a cutting-edge Contract Research Organization providing full-service support to pharmaceutical, biotechnology and medical device companies as well as academic institutions. We offer a range of services that help companies get their new products to market, with a specific focus on vaccines, neglected tropical diseases, rare diseases, metabo...
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At Xcene research, we keep our commitment to improve health and due to continuous growth and strong study pipelines, the Clinical Trial Associate is responsible for supporting study and site management activities, i.e., perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory teams, to ensure a complete and accurate Trial Master File delivery.
Key Accountabilities
Provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).
Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
Support the Clinical Operations teams with ongoing conduct of studies.
Ensure Knowledge of ICH GCP, appropriate regulations, relevant Xcene Research SOP’s and internal tracking systems.
Assist with site visits and co-monitoring.
Assist project teams with study specific documentation and guidelines as appropriate.
Set up, organize and maintain clinical study documentation (e.g., Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
Process Data Collection Forms i.e., log in, tracking, quality control as appropriate for the study.
Assist in quality control audits of clinical study documentation (e.g., Main Study Files, CRF Files, Monitoring Files, etc.).
Co-ordinate ordering/dispatch and tracking of trial materials (e.g., CRFs, diary cards, lab supplies, drug supplies) as appropriate.
Assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
To contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.).
To assist in the tracking and distribution of safety reports.
To co-ordinate document translation, if required.
To attend project team meetings and generate meeting minutes.
To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.
To assist with the coordination of team member tracking.
Skills
Computer skills including working knowledge of Microsoft Word, Excel, and PowerPoint.
Attention to detail, and excellent organizational and prioritization skills.
Attention to detail and excellent oral and written communication skills.
Education and Qualifications
Bachelor’s degree (or equivalent) level of qualification in life sciences or related field or equivalent combination of education and experience.
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