Overview
Clinical Trial Assistant (CTA) – Johannesburg – South Africa Jobs in South Africa at P95
Job purpose
The Clinical Trial Assistant (CTA) will perform technical study duties and support and coordinate the logistical and administrative aspect of assigned clinical studies; perform general project administrative and secretarial services to facilitate the smooth and effective running of the study. CTA ensures administrative compliance with the study protocol, regulatory requirements, and all applicable company procedures. In doing this, the CTA represents P95 with professionalism, integrity, and a keen focus on quality.
Responsibilities
Participate in project set-up activities
Set up Trial master file and prepare mock investigator site file
Organization and support of meetings
Collect regulatory documents from sites for initial regulatory and EC submission
Maintain regulatory and REC submissions and correspondence throughout the conduct of the study as applicable per regulatory and applicable REC requirement
Process study-related invoices, reimbursements, and track
payments from or to internal or external service providers and enter information into tracking system, as applicable and per project management processes
Ensure that all relevant documentation of invoices and
payments is filed in the TMF
Logistic management of non-drug study related supplies/services
Track availability of clinical supplies for the project as applicable
Ensure maintenance of non-clinical supplies at site level
Set-up, maintenance, preparation for archiving and QC checks of the TMF
Set-up and distribution of Investigator Site Files and support PM in conduct of QC checks
Organize archiving of Investigator Sites Files to the independent third-party company, in case that the investigator asks for support when site cannot keep files in a longer term
Process study-related invoices, reimbursements, and track payments from or to internal or external service providers and enter information into tracking system, as applicable and per project management processes
Logistic management of non-drug study related supplies/services
Ensure tracking of all safety reports submitted to applicable EC, regulator, and investigators
Assistance in preparation, support during conduct of audits and inspections of study documents
Experience – the ideal candidate will have
Matric certificate and other secretarial certificate / Diploma or equivalent will be an advantage
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirement
Proven ability to work independently in a fast-paced environment
Strong communication, interpersonal, and organizational skills
Must demonstrate good computer skills, including experience with Microsoft Excel and Word
Understanding of SOPs
Why us?
You will join a young, very dynamic, and fast-growing private research organization. Our passionate, truly multicultural, and diverse team of more than 115 colleagues and nearly 40 nationalities include epidemiologists, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and business support professionals spreading over 20 countries.
We all work remotely, setting our own time schedule, based on a “getting the job done” mentality. This has a positive impact in our work-life balance. Our headquarters are in Leuven (Belgium), but we also have local and regional offices located in Rotterdam (the Netherlands), Bogota (Colombia) and Bangkok (Thailand). You may need to travel occasionally to our Leuven office.
At P95, we are a collaborative and international team that works on diverse projects, topics, and clients and faces interesting challenges. There is a high level of empowerment, flexibility, autonomy as well as opportunities for research and development, to make things happen. We have an open culture of respect and inclusion. Consequently, we value self-reliance, initiative, and responsibility of everyone in our team to meet our internal and external customers’ expectations. Finally, our colleagues experience a strong sense of meaning and purpose driven by the scientific nature and impact of our work.
Do you want to join us?
Visit our website www.p-95.com to learn more about who we are and what we do. If you are the one for this job, send your application by filling out the following short form. The call will remain open until the position is filled.
P95 is an Equal Opportunities Employer. The company is committed to equal employment opportunities regardless of age, sexual orientation, gender, pregnancy, religion or belief, union belief, wealth, birth, nationality, ethnic origin, disability, medical history, skin color, marital status, genetic information, parental status, social origin, or condition. We base all our employment decisions on merit, job requirements and business needs.
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About us
P95, an Ampersand portfolio company, is a global provider of clinical and epidemiological services related to vaccines and infectious diseases.
Founded in 2011, we are a leader in sourcing, analyzing, and reporting epidemiological data to assist health agencies and pharmaceutical companies in improving access to safe and effective vaccines.
Headquartered in Belgium, P95 has also offices in Europe, North America, South America, South Africa, and SE Asia.
We are passionate about healthcare and helping our customers with innovative medical research. We share a sense of urgency with our customers to deliver timely, pragmatic and useful insights to improve healthcare.
Our clients are from the pharmaceutical industry, public health institutes, academic institutions, WHO, the European Commission and other governmental organizations and Non-Governmental Organizations (NGOs). Our projects focus mainly on infectious diseases, particularly on vaccines.
Title: Clinical Trial Assistant (CTA) – Johannesburg – South Africa
Company: P95
Location: South Africa
