To support the design, execution and analysis of clinical trials including administration of clinical site files, assisting with the design of clinical protocols, analysis of clinical data, support in the preparation of final reports and regulatory submissions, and publication management. Office based.

Responsibilities

  • Provide day-to-day project activities, including maintenance of project-related files, update Trial Master File, maintain and provides trial status tracking and progress update reports;
  • Set up investigator site files and administration of clinical trial supplies;
  • Preparation of clinical site contract in cooperation with legal advisors;
  • Identify site problems/deficiencies and bring to the attention to the Clinical Director;
  • Supervise study progress to ensure compliance with and adherence to protocol and timelines of clinical sites;
  • Occasional monitoring on-site or remotely investigator sites to ensure accuracy and validity of CRF entries
  • Track and manage CRFs, handling of queries, documentation of deviations and adverse events;
  • Participating in preparation of the clinical protocols, CRFs, ICF and clinical database;
  • Cooperate with CRO in the completion of the application to Ethics Committee/Competent Authorities in accordance with local requirements;
  • Support site identification, site selection and site initiation;
  • Undertaking literature research, assisting in preparation of project publications, management of publication tools.

Minimum Qualifications/Experience

  • A relevant scientific degree;
  • A minimum of one-year experience as a CRA ideally in medical device clinical monitoring;
  • Knowledge in clinical research regulatory requirements (e.g. GCP, ISO 14155);
  • Excellent communication skills (written and verbal) in English;
  • Flexible, ability to manage multiple competing tasks and achieve project timelines.
  • Previous start-up company experience or an ambition to work in the start-up environment

Personal Attributes

An excellent communicator, ability to multitask, pragmatic, diplomatic, tenacious, and a committed team player.