Overall Purpose of the Position:
The clinical trial assistant (CTA) plays an important role in supporting the daily operations of clinical research studies at the research site and is responsible for a mix of administrative tasks and data management activities to ensure the efficient functioning of study activities. This position requires a detail-oriented individual who can effectively manage documentation, assist with participant interactions, and maintain high standards of data integrity. The role will be primarily linked to the IAVI study but may be applied to other studies at the site where applicable.
Key Performance Areas (KPAs) & Responsibilities include, but not limited to:
Administrative support:
- Document Management: Maintaining Investigator Site Files (ISFs) and essential study documents through filing, scanning, and processing.
- Participant Coordination: Assisting in scheduling participant visits, coordinating and following up on referred participants from recruitment efforts, managing logistics, and ensuring seamless transportation.
- Administering the Clinical Trials Management System(s) for the site’s active studies.
- Communication: Serving as a liaison with Clinical Research Associates, Study Sponsors, and internal teams, providing timely updates and information.
- Meeting Coordination: Organising study team meetings, taking minutes, and disseminating key information to relevant stakeholders.
- General Administration: Handling phone inquiries, managing deliveries, and providing full administrative support to the study team with various tasks.
Data Management and related administrative duties:
- Source Quality Checks: Conducting quality checks on source documents and ensuring proper organization of files by study and time point.
- Data Entry: Accurately capturing and maintaining participant visit information and screening outcomes in the Realtime database and other relevant platforms.
- Tracking and Reporting: Preparing and maintaining logs for participant screening, enrollment, demographics, and visit schedules, ensuring up-to-date records.
- Medical Report and Result Management: Tracking and printing medical reports for investigators, following up on any outstanding items and assisting with query resolution.
Study Documentation:
- Source files: Preparing and checking source files for accuracy and readiness prior to scheduled participant visits.
- Template Maintenance: Ensuring version control of study documentation, including Informed Consent forms and protocols.
- Quality Control: Conducting quality checks on completed source documents to minimize data queries and discrepancies.
Financial administration and management:
- Participant Reimbursement: Processing and maintaining logs for participant reimbursements and assisting with site cash management, where relevant.
Liaison and communication:
- Collaborating with other TASK teams (IT Helpdesk, HR, Regulatory and Quality Office) to facilitate smooth operations across the organization through effective communication and in a cross-functional manner.
Additional Duties:
- Assisting team members with various internal projects and performing other related duties as required.
Ideal Requirements
- A BSc degree or higher qualification in Health Sciences may be advantageous.
- Preferred: 1–2 years of previous experience in clinical research, clinical trials, and/or a similar administrative role, including data capturing
- Familiar with medical terminology and/or knowledge (Advantageous)
- Clinical trial systems knowledge and relevant experience
- Proficient in Microsoft Office Suite.
- Driver’s License (Advantageous).
- Position may require occasional travel between different TASK sites (TASK Delft Primary Site).
- Flexibility in working hours may be necessary to accommodate study related and participant requirements.
Key Personal Inherent Characteristics
- Effective and Professional use of the English Language; both written and verbal.
- Clinical trial systems knowledge and relevant experience.
- Attention to detail and commitment to maintaining data integrity.
- Ability to work independently as well as collaboratively within a team.
- Able to work in a fast-paced environment.
Please indicate in your application that you are applying for the above-mentioned position (full title), notice period and gross salary expectations.
If you have not received a response within one month, your application was most likely unsuccessful.
TASK reserves the right to withdraw this advertisement and not fill the above-mentioned vacancy at any stage during the recruitment process.
Meeting our employment equity goals will be acknowledged during the recruitment process
By responding to this advert and sending your cv, cover letter and/or any other documentation, you are consenting to TASK processing your personal information as contained in the furnished documents. TASK may process your personal information for recruitment purposes for suitable posts that may arise within the organisation. You agree that you have familiarised yourself with South Africa’s Protection of Personal Information Act and understand your rights and obligations under this Act.
