CRCJDProject ManagerPage 1 of 1

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/ University of Cape Town
Clinical Research Centre / Job description
Title / Project Manager
Date
Activities / objectives / tasks / Competencies
Ensures compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements as regards:
  • Developing and maintaining the Investigator Site File and/or its contents, ensuring this and participant files are stored in a safe and secure environment.
  • Developing and maintaining relevant project management tools, including tracking and/or reporting of project metrics, progress reports and any other relevant documents timeously and meticulously to meet study requirements.
  • Overseeing sourcing of protocol-specific equipment and supplies whether clinical or related to catering, recreation etc.
  • Ensuring facilities are suitable for day-to-day operations.
  • Working with the investigators and other study staff to ensure recruitment targets are met and visit schedules adhered to, including placing of adverts, and trouble-shooting losses to follow-up.
  • Ensuring that quality control measures relating to data collection and other processes are implemented.
  • Ensuring adverse event reporting is according to the protocol and regulatory requirements.
  • Liaising with other departments or collaborators (e.g. cardiology, laboratory) where necessary such that project-specific tasks are conducted correctly and within any contract.
  • Liaising between monitors and the project team as regards scheduling of monitoring visits and associated activities (e.g. outstanding actions).
  • Assisting with the organisation of project team meetings.
/ - Good Clinical Practice certification
- Applicable research experience
- Good communication interpersonal skills
- Attention to detail
- Writing and computer skills
  • Developing and communicating staff schedules based on the protocol and study timelines.
  • Ensuring staff comply with any research ward requirements (e.g. access control, emergency evacuation procedures).
  • Facilitating or leading training where appropriate.
  • Maintaining training records as per SOPs.
/ As above plus:
- Administrative and management skills
- Time management
- Performing assessments (if necessary according to qualification), in accordance with the protocol, SOPs, and regulatory requirements. / - Role-specific qualification and experience
- Reviewing financial reports for accuracy, investigating irregularities and liaising with the finance department where necessary as regards purchases/payments/reports etc. / - Numeracy

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