Clinical Trial Assistant

**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, data management activities, and sample processing and management to ensure the efficient functioning and performance of study activities. This position requires a detail-oriented individual who can effectively manage all samples in compliance with relevant protocols, maintain documentation and high standards of data integrity.

**Key Performance Areas (KPAs) & Responsibilities include, but not limited to**:
**Administrative Support**:

- Document Management: Maintaining relevant study documents through receiving, filing, and processing of documents as required.
- Participant Visit Coordination: Assisting in preparing and coordination for participant visits.
- Communication: Serving as a liaison with Clinical Research Associates, Study Sponsors, and internal teams, providing timely updates and information.
- Meeting Coordination: Organising and attending study team meetings, take minutes, and disseminating key information to relevant stakeholders, where indicated.
- General Administration: Managing deliveries and providing 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 capture and maintain relevant participant visit information and screening outcomes in the Realtime database and or other relevant platforms.
- Tracking and Reporting: May need to prepare and maintain logs for participant screening, enrolment, demographics, and visit schedules, ensuring up-to-date records in addition to processing room related logs and spreadsheets.
- Medical Report and Result Management: Tracking and printing medical reports and or results for investigators, following up on any outstanding items and assisting with query resolution.

**Study and Processing Room Documentation**:

- Source files: Preparing and checking source files for accuracy and readiness prior to scheduled participant visits, if necessary.
- Template Maintenance: Ensuring version control of study documentation, protocols, including laboratory manuals, logs and guiding tools.
- Quality Control: Conducting quality checks on completed documents, requisition forms and logs to minimize data queries and discrepancies.

**Sample Processing and Management**:

- Site readiness: Assisting with start-up and site readiness activities for new studies and or amendments as needed.
- Sample Collection Coordination: Overseeing and managing the collection of clinical research samples, ensuring compliance with study protocols.
- Specimen Preparation: Preparing specimen containers for safe collection, ensuring proper labelling, documentation, and storage as per protocol.
- Lab Kit Management: Receiving lab/specimen kits, checking expiry dates, and ensuring completeness as per study requirements. Re-ordering kits to maintain sufficient stock.
- Quality Standards Improvement: Upholding and improving processing standards; reporting quality risks to the Supervisor/Manager.
- Training: Actively participating in investigator meetings, site initiation visits to ensure understanding of protocols and laboratory manuals and remain up to date with training and amendments.
- Sample Processing Activities: Performing centrifugation and aliquoting of samples according to established procedures, maintaining accurate records.
- Sample Packaging and Shipping: Packing samples as per lab manuals and arranging secure shipment, completing necessary documentation.
- Storage Management: Storing samples in appropriate conditions (freezer/fridge) and maintaining accurate logs of contents.
- Procedure Development: Developing and assisting in training on procedures for sample processing as per study protocol.
- Quality Control Systems: Implementing and maintaining quality control systems for sample collection, processing, shipping and storage.
- Temperature Monitoring: Monitoring and documenting fridge and freezer temperatures daily, ensuring compliance with SOPs and reporting excursions.
- Sample Shipment Preparation: Preparing samples for shipment, ensuring secure delivery as per study protocol, and verifying completeness of logs before shipping.
- Sample Documentation: Preparing and maintaining accurate records and or sample logs/inventories, tracking samples, supporting data integrity and chain of custody of all samples received, processed, stored and shipped, ensuring up-to-date records completed in real-time.
- Equipment: Operating and maintaining equipment in compliance with instruction manuals and SOPs.
- Temperature control and excursions: Maintaining, documenting and monitoring correct storage and shipping temperatures per requirements,