Clinical Research Associate II (CRA II)

Sponsor Dedicated

Johannesburg Based

The CRA II performs site monitoring and management activities to ensure clinical studies are conducted in accordance with study protocols, applicable regulations, and sponsor requirements.

Key Responsibilities

• Conduct site monitoring visits (selection, initiation, routine monitoring, and close-out) in line with GCP, ICH guidelines, and contracted scope

• Drive and support subject recruitment strategies at site level to meet enrollment targets

• Deliver protocol and study-related training and maintain effective communication with investigative sites

• Assess site performance to ensure quality, data integrity, and regulatory compliance; escalate issues as needed

• Track study progress including regulatory submissions, enrollment, CRF completion, and query resolution; support study start-up where required

• Ensure essential documents are complete and filed appropriately in the TMF and maintained in the Investigator Site File (ISF)

• Prepare monitoring reports, follow-up letters, and maintain accurate site documentation

• Collaborate with cross-functional study teams to support project delivery

• Support site-level recruitment planning and, where applicable, site financial management activities

Qualifications & Experience

• Bachelor’s degree in life sciences or healthcare (or equivalent combination of education and experience)

• Minimum 2 years of on-site monitoring experience

• Mandatory Oncology therapeutic area experience

• Strong knowledge of GCP, ICH guidelines, and clinical research regulations

• Good therapeutic area and protocol understanding

• Proficiency in Microsoft Office (Word, Excel, PowerPoint)

• Strong communication, organizational, and problem-solving skills

• Ability to manage time, priorities, and stakeholder relationships effectively