Clinical Operations Specialist

Position Description

Job Title: Clinical Operations Specialist

Location: South Africa

Reports to:     Associate Director, Clinical Operations

Position Summary:  

IAVI is seeking a highly motivated Clinical Operations Specialist (COS) who will be responsible for the day-to-day operational activities enabling the conduct of clinical trials according to ICH/GCP guidelines. The successful candidate will support the Clinical Trial Manager (CTM) by managing clinical aspects of the trials, including site management and monitoring. 

Key Responsibilities:

Clinical Operations:

• Manage clinical vendors (including on-site monitors / CRO) and oversee relevant sections of the Protocol Management Plan. Management and oversight includes, but is not limited to the following activities: 

1. Lead point of contact for clinical vendors
2. Support vendor selection and contracting 
3. Train vendors 
4. Monitor vendor performance against contract, ICH GCP, relevant SOPs, local Regulatory and ethical standards and protocol; includes site visit report review and quality oversight visits
5. Track vendor invoices for accuracy and against contract, send invoices for processing and payment.

• Provide initial and ongoing training to other departments and site staff to support the conduct of clinical trial activities. 
• Conduct risk planning and mitigation for vendors and clinical activities and work with CTM to mitigate risks and solve issues.
• Review, provide input, and draft assigned sections of key study documents.
• Ensure approved monitoring plan is in place.
• Develop quality oversight plan for monitoring activities.
• Assist CTM in establishing study timelines and budgets for clinical aspects of trials and ensure clinical activities are conducted within timelines and budget.
• Manage and oversee the completeness and accuracy of the Trial Master File (TMF) through appropriate reviews of all study related information, ensuring TMF is inspection ready.
• Work with CTM and other departments to oversee data quality through various means including data listings reviews.  
• Prepare for and conduct site visits as needed, including site qualification, study initiation, interim monitoring, and close-out visits.
• Provide study status updates to project team and management as needed.
• Act as clinical operational lead on observational studies as assigned.
• Oversee studies that IAVI monitors for other sponsors.

Departmental and knowledge development activities:

• Participate in/initiate Clinical Development departmental activities as assigned e.g., drafting/reviewing operational procedures, participating in departmental meetings, etc.
• Provide support and back-up to senior departmental personnel as needed, such as attending meetings, assuming lead in study team meetings or ad-hoc meetings, generating and/or reviewing minutes, and following up on action items.
• Remain up to date on knowledge of clinical trial methodology, ICH GCP, FDA regulations, EMA Regulations, and other local/international regulatory and ethical guidelines and requirements.
• Remain abreast of scientific knowledge of targeted disease and population and investigational product(s).
• Participate in training activities for new staff, as needed.

Education and Work Experience:

• Undergraduate degree in a scientific or related field is required.
• Minimum 5 years of clinical trials experience is required, including clinical monitoring, preferably with clinical team lead experience.

Qualifications and Skills: 

• Ability to conduct presentations of technical information concerning specific projects is required.  
• Outstanding interpersonal skills and ability to work effectively in a cooperative and collaborative manner with all levels, and across functional teams both internally and externally is required.
• Ability to work on problems of moderate complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is required.
• Excellent project planning and implementation skills in a cross-disciplinary and multi-cultural team are required.
• Excellent knowledge of ICH GCP and FDA CFR guidelines as well as the Declaration of Helsinki and relevant country specific regulations are required.
• Excellent oral and written communication skills are required.
• Proven ability to coordinate and lead multi-disciplinary project teams is required.
• A professional demeanor, as well as a pleasant manner and positive "can-do" attitude is required.
• Flexibility to change priorities and be comfortable with changing deadlines to meet organizational needs is required. 
• Excellent computer skills and proficiency in Microsoft Word and Excel is required.
• Ability to travel up to 50% of the time is required
• High level of independence in performing responsibilities is highly desirable. 
• Ability to mentor other staff including Clinical Trial Associates and Clinical Research Associates 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 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 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.