Clinical Research Associate (CRA I and CRA II) - Johannesburg
11 days ago
We are currently recruiting for a leading CRO who is looking to employ a CRA I and a CRA II for various trials.
As a CRA, you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP.
Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule.
Adheres to project guidelines and the company's SOPs for monitoring requirements.
Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
Collects and reviews regulatory documents as required.
Prepares site visit reports and telephone contact reports.
May participate in the start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, and developing study documents.
Resolves site issues, including site recruitment challenges and determines status for IP shipment.
Works with Project Manager (PM), Clinical Team Leader and/or LCRA (CTL/LCRA), regulatory team members or sponsors to secure authorization of regulatory documents and site contracts.
Informs team members of completion of regulatory and contractual documents for individual sites.
Attends Investigator Meetings (IM) and study specific training meetings.
Performs internal in-house monitoring tasks.
Prepares and attends an Assessment Visit with a more senior CRA, Clinical Team Leader or Clinical Research Manager as required.
Assists the Project Team with the day-to-day management of clinical studies as required, including attendance at team meetings.
South African ID or valid Work Permit
Relevant Sciences / Biotech / Medical related degree or Diploma
Minimum of 2 years' CRA experience in phase I-III trials
Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
Able to travel