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Our client is seeking an experienced ‘Home-Based’ Clinical Research Associate (CRA) to add to their growing pharmaceutical research endeavors.
Therapeutic areas include but are not limited to Oncology, Cardiovascular, Osteoporosis and Respiratory.
We are looking for committed individuals based in Centurion or Johannesburg to work in a busy clinical research department providing essential monitoring support.
ROLE AND RESPONSIBILITIES
The CRA oversees the progress of a Clinical Trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.
The role provides the opportunity to develop monitoring skills with advanced responsibilities, critical and central to the conduct of the clinical project.
This position will be home based after an initial on-boarding period. The position will be sponsor dedicated, thus you will only be working with one specific sponsor. Travel will be kept to a minimum to encourage a work life balance culture throughout the company.
• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• May provide assistance to less experienced clinical staff.

REQUIREMENTS

• 1 year + experience in clinical research as a research associate.
• Must have Medical or Life Science degree or qualification.
• Good knowledge of (GCP) Good Clinical Practice.
• Valid driver’s license with own vehicle.
• Proficiency in MS Word and Excel.