Clinical Trial Associate

Position Summary

Job Title: Clinical Trial Associate

Location**:** Cape Town, South Africa; Remote - South Africa

Reports to: Director, Clinical Operations

Are you a Clinical Operations professional who is eager to make an impact in a mission-driven organization?

IAVI is seeking an ambitious Clinical Trial Associate to execute operational activities in support of clinical trial execution. The CTA works closely w/ the Clinical Trial Manager, CRAs, and clinical team to maintain the eTMF, track site documents, keep meeting minutes, and handle other ad-hoc clinical study team activities. The CTA is a key in supporting the execution of highly complex clinical trials, including the onboarding, and mentoring of new clinical operations staff.

Build on your clinical operations experience while helping to translate science into global health solutions and apply below!

Key Responsibilities:

• Serve as eTMF business administrator, manage system updates, train and on-board internal and external staff, and manage access control.
• Collect and track regulatory documents, other essential documents, and lead reviews of the eTMF ensuring all required documentation is on file.
• Liaise with site staff, investigators, Contract Research Organizations (CROs), and other vendors/collaborators as needed, maintaining accurate and timely completion of tasks assigned.
• Provide administrative and logistical support (scheduling, distributing agendas, taking and distributing minutes/action items) for teleconferences, internal and external meetings, trainings, or other meetings, and track supplies and equipment for the sites.
• Assist the clinical operations team in creating study documents while providing general support of the teams use of the eTMF and QualityDocs supporting workflows and management of metadata.
• Contribute to clinical study operations through tasks such as project tracking, audits, and maintenance of regulatory databases such as ClinicalTrials.gov.
• Anticipate/identify potential problems, write deviations, implement corrective actions, and escalate where appropriate.
• Serve as a member of the SOP task force as needed, contributing to the Clinical Development departmental Standard Operating Procedures for conduct of clinical trials, ensuring adherence to regulations/guidelines for GCP.
• Develop, maintain, and distribute reports from eTMF on both trial and organizational level to support documentation and metrics for multiple IAVI stakeholders.
• Serve as the business administrator of the LMS, providing programming support and generate reports for both CD training items and protocol specific training items.
• Perform other duties as assigned.

Education and Experience:

• Bachelor’s degree is required, preferably in a scientific field.
• Minimum 2 years of clinical operations experience.
• Experience as Clinical Trial Associate or in other clinical trials-related administrative support or equivalent is required.

Qualifications and Skills:

• Demonstrated understanding of clinical trial operations and research principles is required.
• Strong organizational skills, including the ability to work on multiple projects with overlapping schedules and flexibility, as well as to be able to change priorities to meet deadlines and organizational needs is required.
• Ability to work both independently and collaboratively in large, complex, cross-functional project teams is required.
• Attention to detail is required.
• Excellent verbal and written communication skills are required.
• Ability to complete tasks on time and with high quality is required.
• Critical thinking skills, with the ability to identify problems and possible solutions, and assess impact on timelines is required.
• Ability to work effectively with teams of diverse educational and cultural backgrounds and maintain a high standard of professional conduct as a representative of IAVI is required.
• Computer and technological literacy, proficiency in Microsoft Office Suite, and ability to quickly learn and master new systems is required.
• Experience in electronic Trial Master File software such as Veeva or similar eTMF system is highly desirable.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.

IAVI CORE VALUES:

• Commitment: We deliver on our mission, proactively transforming promises into tangible results
• Stewardship: We steward IAVI's resources responsibly to ensure IAVI's long-term success and global health impact
• Integrity: We uphold strong moral principles to maintain our credibility as a nonprofit scientific research organization
• Collaboration: We work as one IAVI team and partner with others to deliver globally accessible, urgently needed, public health solutions

Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship. IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

IAVI is an equal opportunity employer. It is IAVI’s policy to provide equal opportunity without regard to race, citizenship, color, sex, gender identity or expression, age, height, weight, disabili