Clinical Operations Specialist

**Position Description**

**Job Title**:Clinical Operations Specialist
**Location**: Cape Town, or Remote in South Africa
**Reports to**: Associate Director, Clinical Operations

**Position Summary**:
Help IAVI translate science into global health impact as a Clinical Operations Specialist

IAVI is seeking an ambitious 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 Clinical Operations Specialist 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. Responsibilities include, but are not limited to the following activities:

- Lead point of contact for clinical vendors
- Support vendor selection and contracting
- Train vendors
- 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.
- Track vendor invoices for accuracy and against contract and 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 working with CTMs (Clinical Trial Managers) 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, while 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 and Quality Oversite 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.
- Perform other duties as assigned.

**Education and Work Experience**:

- Bachelor’s degree in a scientific or related field is required.
- Minimum 5 years of clinical trials experience including clinical monitoring is required.
- Clinical team lead experience is preferred.

**Qualifications and Skills**:

- Ability to conduct presentations of technical information concerning specific projects is required.
- 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.
- 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.
- Flexible and adaptable to accommodate 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 a maximum of 50% of the time occasionally is required.
- High level of independence in performing responsibilities is highly de