Clinical Trial Associate

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Execute operational tasks to support the execution of clinical trials.

• Collaborate closely with the Clinical Trial Manager, CRAs, and the clinical team.

• Oversee the eTMF, managing system updates, access control, and onboarding/training of staff.

• Monitor site documents and gather regulatory and essential documentation.

• Conduct eTMF reviews to verify that required documentation is properly filed.

• Act as a liaison with site personnel, investigators, CROs, vendors, and collaborators.

• Provide administrative and logistical assistance for teleconferences, meetings, training sessions, and other gatherings.

• Schedule meetings, distribute agendas, and take as well as share minutes/action items.

• Monitor supplies and equipment for clinical trial sites.

• Assist in the development of study documents and support eTMF and QualityDocs workflows along with metadata management.

• Contribute to project tracking, audits, and the upkeep of regulatory databases such as ClinicalTrials.gov.

• Identify potential issues, document deviations, implement corrective measures, and escalate when appropriate.

• Contribute to the development of departmental SOPs and ensure compliance with GCP regulations and guidelines.

• Create, maintain, and distribute eTMF reports for trial and organizational stakeholders.

• Serve as the LMS business administrator, offering programming support and generating training reports.

• Assist in onboarding and mentoring new clinical operations personnel.

• Perform additional duties as assigned.

⛳️ Requirements

• A Bachelor’s degree is required, preferably in a scientific discipline.

• At least 2 years of experience in clinical operations is necessary.

• Experience as a Clinical Trial Associate or in other clinical trial-related administrative support roles or equivalent is mandatory.

• Proven understanding of clinical trial operations and research principles.

• Strong organizational abilities, including the capacity to manage multiple projects with overlapping timelines and adaptability.

• Ability to work independently as well as collaboratively in large, complex, cross-functional project teams.

• Keen attention to detail.

• Exceptional verbal and written communication skills.

• Ability to complete assignments punctually and with a high standard of quality.

• Critical thinking skills with the capability to identify issues, propose solutions, and assess their impact on timelines.

• Ability to work effectively with teams from diverse educational and cultural backgrounds while maintaining a high standard of professionalism as a representative of IAVI.

• Proficient in computer and technology literacy.

• Proficient in Microsoft Office Suite.

• Ability to quickly learn and master new systems.

• Experience with electronic Trial Master File software, such as Veeva or a similar eTMF system, is highly desirable.

🏝️ Benefits

• Generous employer contributions to retirement savings plans.

• Competitive health, dental, and vision insurance plans.

• Competitive paid time off policy.

• Potential for annual bonuses based on performance.

• Additional benefits.