Clinical Trial Associate

Position Description

Job Title: Clinical Trial Associate
Location: Nairobi, Kenya, or Remote (East Africa)

Position Summary:

IAVI is seeking to hire an outstanding Clinical Trial Associate (CTA) who would be responsible for administrative and operational activities enabling the conduct of clinical trials according to ICH/GCP guidelines. The successful candidate works closely with the Clinical Trial Manager and CRAs to maintain the eTMF, track site documents, keep meeting minutes, and handles additional responsibilities for the study team. This position provides crucial support for the team and gives exposure to the day-to-day operations that goes into clinical studies.

Key Responsibilities:

• Serve as eTMF business administrator, manage system updates, train and on-board internal and external staff, and manage access control.
• Collect, review and track regulatory documents, and other essential documents, to facilitate reviews of the eTMF and ensure all required documentation is on file.
• Interface and maintain good relations with site staff, investigators, Contract Research Organizations (CROs), and other vendors/collaborators, as needed, to ensure 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.
• Contribute to clinical study operations by providing administrative support for project tracking, audits, and maintenance of regulatory databases, such as ClinicalTrials.gov.
• Contribute to the coordination and tracking of study related documents, supplies and equipment to the sites.
• Support the study team with financial management of clinical trials including tracking, reviewing and processing invoices, as needed, and loading contract requests in contract central.
• Anticipate/identify potential problems, implement corrective actions, and escalate where appropriate.
• When requested, contribute to the Clinical Development Standard Operating Procedures for conduct of clinical trials based on IAVI templates and ensure adherence to regulations/guidelines for GCP.
• Perform other duties as assigned.

Education and Experience:

• Bachelor’s degree is required.
• Minimum 3 years of experience in clinical trials-related administrative support or equivalent is required.

Qualifications and Skills:

• Computer and technological literacy, proficiency in Microsoft Office Suite, and ability to quickly learn and master new systems is required.
• 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.
• 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.

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 actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific global non-profit. IAVI upholds these principles through IAVI’s Global Diversity and Inclusion Committee.

IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.