Clinical Research Associate

A progressive Healthcare Company who is passionate about providing Clinical Care to HIV positive adults, children and adolescents is currently looking for a dynamic and driven Clinical Research Associate to collaborate with sites to ensure timeous entry of data in electronic CRFs for in stream review and analysis of data by data management

Key performance areas
• Supervision of site staff.
• Assignment of tasks to Clinical Trials Assistant.
• Initiate and facilitate all study related payments as per agreed study budget.
• Supervision of collection /delivery of study supplies or documents.
• Act as the main line of communication between the sponsor and the investigator
• Build lasting and productive relationships with internal and external customers by presenting a positive and ethical company image.
• Remain abreast of scientific knowledge through literature review and clinical training courses.
• Liaises with Medical Advisor(s) and Clinical Trial Manager to identify suitable investigators for clinical trials.
• Verifies that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout the study
• Submits high quality and timeous applications and amendments for Regulatory & Ethical approval in compliance with SOPs, ICH GCP Guidelines and local regulations.
• Assists Clinical Trial Manager to draw up a mutually acceptable and accurate financial/study agreements to ensure optimum management of local trial budgets.
• Responsible for the safety and proper conduct throughout the trial
• Verifies that the investigator follows the approved protocol and all GCP procedures
• Verifies that source data/documents and other trial records are accurate, complete, and maintained in compliance with SOPs, ICH GCP to ensure high quality data which is acceptable for regulatory submissions.
• Reports adverse events, concomitant medications, and inter current illnesses in accordance with the protocol, SOPs and local regulatory requirements.
• Communicates deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator, study teams, ethics committees and regulatory authorities.
• Tracks and achieves recruitment targets, data entry and data query resolution requirements in order to meet project milestones and timelines.
• Utilise and maintain R&D IT resources and systems (eg RAMOS, Xpress, eTrack, Study Portal and Document Exchange) for the efficient conduct of clinical trials.
• Assists all parties in the preparation fot internal and external assessments and inspections.
• Identifies opportunities for adaptive site monitoring visits through individual site risk assessments.

Education, Training and Experience
• Tertiary Health Sciences Master’s Degree
• Minimum 2 years clinical trial monitoring experience.
• GCP certification
• Professional use of the English language; both written and oral
• Open and clear communicator
• Confident and influential approach
• Make independent choices and take responsibility for own actions
• Understand the needs of others
• Coordination and planning of budgets, people and time management
• Recognize potential obstacles and work to resolve them within set timelines
• Conscientious and precise delivery of work even when under pressure
• Negotiating skills
• Computer literacy
• Basic statistical skills