Clinical Trial Assistant

**About the Company**:
TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas.

**Overall Purpose of the Position**:
As a highly organised and detailed-oriented individual, the Clinical Trial Assistant will be responsible for managing the processing and handling of clinical research samples in compliance with relevant policies, procedures and regulatory standards. The role involves coordinating the receiving, processing, storing and shipment of all specimens as well as assisting with daily administrative tasks, ensuring accuracy and adherence to study protocols.

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

- Coordinating and overseeing the collection of clinical research samples
- Preparing specimen containers for safety specimen collection, ensure proper labelling, documentation and storage of samples as per protocol
- Receiving lab / specimen kits, checking expiry dates and completeness of kits as per study requirements and visit schedule; re-ordering kits as may be needed to ensure sufficient stock at all times
- Notifying senior of expired kits, removing from stock and suggesting, where appropriate, alternative measures in the event of potential challenges related to expired kits
- Improving and upholding processing standards, and reporting quality risks to the Supervisor/Manager
- Attending and participating actively in investigator meetings and/or site initiation visits / training to ensure understanding of the protocol and study laboratory manuals to perform required procedures accurately while adhering to all specified timelines
- Performing sample processing activities such as centrifugation and aliquoting of safety samples, according to established procedures and manuals, adhering to accurate record-keeping and documentation of procedures
- Storing samples / specimen in freezer / fridge as required, ensuring accurate documentation of the contents of fridges and freezers at all times and for all studies (sample logs/sample inventories)
- Developing procedures where necessary for the processing of samples as per study protocol, for further review, consideration and approval by management; assisting with training thereof where necessary
- Implementing and maintaining quality control systems to ensure and provide guidance for the correct collection, processing and storage of all study samples
- Conducting quality control checks to ensure the integrity and accuracy of collected and processed samples and maintaining relevant quality assurance standards
- Monitoring and documenting fridge and freezer temperatures daily through the continuous temperature monitoring system to ensure storage temperatures are within applicable range and reporting if not as per SOP. Assisting with temperature excursion reporting; taking all efforts to protect the integrity of samples e.g. moving samples to backup freezer or to another site
- Preparing shipment of samples, completing all necessary shipment documentation, arranging pick up of samples to be shipped and ensuring secure delivery as per relevant procedures and study protocol
- Checking for completeness and accuracy of all participant specimen logs and requisition forms before shipping samples; copy logs and record in the site files
- Tracking and printing medical reports for doctor and follow up on outstanding medical reports
- Communicating effectively with internal and external stakeholders as may be required
- Performing clinical administrative duties / miscellaneous duties as requested and required
- Conducting source quality checks; preparing files for data capturing and capturing source document data into study database
- Maintaining study documents by filing, receiving and processing source and other study documents, including scanning, copying, filing, and checking documents where required
- Being on standby to respond to temperature alerts

**Ideal Requirements**
- Tertiary qualification in related field
- Minimum two years’ experience working in a clinical trial environment
- Experience in a lab environment, including understanding sample centrifugation, micro-pipetting, capturing into lab database, storage and shipment
- Knowledge of thermometers and central monitoring systems
- Good computer competency in Microsoft Word, Excel and Outlook
- Administrative skills

**The following will be advantageous**:

- Knowledge and/or experience of lab database/s
- IATA training
- Valid GCP certificate
- Knowledge and/or experience of GCLP standards
- Valid driver’s license

**Key Personal Inherent Characteristics**
- Good planning and organizing skills to ensure accurate processing under adverse conditions
- Accurate, neat and meticulous documentation of processes
- Able to multi
- task