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Clinical Trial Administrator

3 months ago

Cape Town, Western Cape, South Africa TASK Full time

Overall Purpose of the Position:


The Clinical Trial Administrator (Paradigm) works at the research site performing daily laboratory safety and microbiology data entry, assist with receiving, processing, storing, shipment of all specimens and administrative tasks ensuring the optimal and smooth running of the day-to-day study activities.

The role will be primarily linked to Paradigm (Unite4TB-002) study but may be applied to other studies at site where applicable.


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

Sample Processing

  • Assisting with receiving of lab / specimen kits, checking of expiry dates and completeness of kits as per visit schedule throughout the study
  • Re ordering of kits promptly to ensure sufficient stock at all times
  • Assisting with preparing of tubes / specimen containers for safety bloods / specimen collection (precise labelling participant initials, visits etc.) before the actual visit as requested by protocol
  • Centrifuging 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 by the protocol and / or lab manual, and documenting contents of fridges and freezers every working day to know the exact content inside freezers / fridges at any given time point for all studies
  • Checking and documenting fridge and freezer temperatures daily and indicating if they are within the required range (report if not, as per SOP)
  • Keeping track of possible temperature excursions. Moving samples to the backup freezer, at another site, if needed
  • Assisting in preparing the shipment of samples and completing all necessary shipment documentation (only if IATA trained)
  • Checking the completeness and accuracy of all participant specimen logs before sending with the shipment samples and copying and filling it in the site files

Data Capturing

  • Conducting source and laboratory report quality checking and sorting of source files by study and time points for data capturing.
  • Capturing of laboratory safety and microbiology data and source document data where applicable into study database.

Study Administration

  • Maintaining study documents by filing, receiving, and processing source and other study documents, including scanning, copying, filing and checking documents where required
  • Conducting quality checks on completed source documents to minimise queries
  • Assisting with general administration, answering of telephone, directing calls, taking messages etc.
  • Coordinating meetings and taking minutes, communicating key information to the study team including regulatory and quality team
  • Uploading and disseminating study communication and organisational information to and from sites and departments
  • Liaising with other TASK departments
  • IT helpdesk, HR, Regulatory and Quality office.
  • Providing full administrative support to the study team for example, responding to sponsor queries, stationery orders, printing, filing, kitchen orders, health and safety, leave and timesheet logs
  • Performing other duties as required, including assisting team members on various internal projects

Ideal Requirements

  • Minimum 2 years of experience in a laboratory or administrative role in clinical trials
  • Experience in a laboratory environment, including understanding of sample centrifugation, micropipetting, data capturing into lab database, storage and shipment
  • Basic medical knowledge (Preferable)
  • Computer proficiency in Microsoft Word, Excel, and Outlook (Essential)
  • 12 years of basic data capturing experience in a similar environment (Essential)
  • Driver's License: Manual Transmission (Advantageous)
  • IATA training (Advantageous)
  • Valid GCP certificate (Advantageous)

Key Personal Inherent Characteristics

  • Great written and verbal communication skills
  • Excellent leadership skills, including goal setting, motivation and training
  • Exceptional interpersonal skills to work with various departments
  • Good problemsolving, critical thinking and decisionmaking skills (Analytical mindset)
  • Exceptional organization, time management and multitasking abilities
  • Keen attention to detail
  • May need to work outside of normal working hours

Details:

Area:
Brooklyn, Cape Town

Contract Type: 12 months fixed-term

Applications Close:25 June 2024


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.

Job Types:
Full-time, Temporary

Contract length: 12 months

Application Question(s):

  • Do you have experience in a laboratory environment, including understanding of sample centrifugation, micropipetting, data capturing into lab dat