Clinical Trial Administrator - Cape Town, South Africa - TASK
Description
Overall Purpose of the Position:
The Clinical Trial Administrator will be responsible for the receiving, processing, storing, shipment of all specimens and assisting with daily administrative tasks.
Key Performance Areas (KPAs) & Responsibilities include, but not limited to:
- Receiving of lab / specimen kits, checking of expiry dates and completeness of kits as per visit schedule throughout the study.
- Notifying the Site Manager of expired kits and remove from shelf to prevent usage.
- Re ordering kits in time to ensure enough stock at all times.
- Attending to and participating actively in investigator meetings and/or site initiation visits / training to ensure that you have understood protocol and study laboratory manuals and can perform required procedures accurately while adhering to all specified timelines.
- Preparing tubes / specimen containers for safety bloods / specimen collection (precise labelling participant initials, visits etc.) before the actual visit as requested in protocol.
- Centrifuge safety samples as per lab manual to separate blood cells and plasma and performing aliquot as per manual.
- Packing of samples / specimen as indicated in the lab manual and informing the necessary parties for collection.
- Storing of samples / specimen in the freezer / fridge as required in the protocol and / or lab manual and documenting contents of the fridges and freezers for every working day to know the exact contents inside the freezers at any given time point for all studies.
- Establishing, developing and implementing processes and procedures.
- Checking and documenting fridge and freezer temperatures daily and indicate if in range (report if not as per SOP). Knowledge of thermometers and central monitoring systems is mandatory.
- Keeping track of possible temperature excursions. Moving samples to backup freezer, at another site, if needed
- Preparing shipment of samples and completing all necessary shipment documents (only if IATA trained)
- Arranging the pickup of samples to be shipped.
- Checking for completeness and accurateness of all participant specimen logs before sending with shipment samples and copying logs and filling it in the site files
- Performing clinical administrative duties / miscellaneous duties and requested.
- Case Report Form (CRF) writing or electronic Data entries
- Conducting source quality checks and sorting of files by study and time point for data capturing and capturing of 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.
- Maintaining, processing, communicating and assisting with all other study administration and office administration responsibilities as required.
Ideal Requirements
- Bachelor of Science degree in related field or relevant qualification
- Minimum two years' experience working in a clinical trial environment.
- Experience in a lab environment, including understanding sample centrifugation, micropipetting, capturing into lab database, storage and shipment.
- Computer literacy able to use Word, Excel, PowerPoint and Outlook at intermediate level.
- Excellent administrative skills
- Flexibility to assist with other tasks and rotate between various TASKS sites, (Delft Primary site).
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
- Professionalism
- Good time management skills
- Written and verbal communication skills in English
- Able to follow detailed written instructions as set out in the lab manual.
- Able to take initiative and work independently.
- Problem solving skills.
Area:
Delft, Cape Town
Contract Type:
Permanent
Applications Close: 24 May 2023
- TASK reserves the right to withdraw this advertisement and not fill the abovementioned vacancy at any stage during the recruitment process._
- Meeting our employment equity goals will be acknowledged during the recruitment process._
Job Types:
Full-time, Permanent
Application Deadline: 2023/05/24
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