Reports to: Senior Director Global Clinical Operations
The Director, Community Engagement provides overall oversight of the implementation of Good Participatory Practice (GPP) at all clinical research centers (CRCs) involved in IAVI clinical research from formative research through to post trial engagement. either directly, through the management oversight of IAVI Community Engagement personnel, or through collaboration with CRCs and other stakeholders. Key elements of this role include developing and driving the overall strategy and plans for GPP implementation in support of IAVI trials and observational studies, training and supporting site community liaison officers (CLOs), counselor supervisors (CS) and Community Advisory Boards (CABs) on GPP, research, vaccines and key concepts related to TB, HIV and other emerging infectious diseases; writing and implementing GPP plans per protocol; and facilitating networking across CRCs.
• Develop strategy for community engagement and GPP in support of clinical trials at IAVI
• Supervise staff to carry out community engagement and GPP in support of clinical trials at IAVI. Includes regular check-in meetings, overseeing training and career development, and assessing performance of direct reports and addressing areas for development.
• Accountable for determining resource needs for current and projected studies and hiring qualified staff. Includes:
o Work closely with Senior Director, Global Clinical Operations and VP and Head of Clinical Development to ensure staffing needs are identified, FTEs and/or consultants are requested and approved as needed
o Lead hiring process for community engagement and GPP in support of clinical trials at IAVI
o Onboard/train new hires
• Working closely with relevant staff, including clinical, laboratory, epidemiology and others as needed, oversee the development and implementation of study-level GPP Plans including determining key deliverables, budgets and timelines and providing this input to management and study teams and reporting back on progress against plans, deliverables, timelines and budgets regularly.
• Study level plans and implementation are to include at a minimum:
o Assessment of each CRC’s GPP implementation readiness to identify any needs (e.g. suitability of CAB, GPP training, research literacy gaps in community);
o Plans to address GPP implementation needs at each CRC (including training of CLOs, CS and CABs on GPP, research, vaccines and key concepts related to TB, HIV and other emerging infectious diseases as needed, ensuring CRCs have an effective CAB in place representative of the study population);
o Facilitation of protocol and informed consent form review and input by CLOs and CABs, presenting this feedback to study team for implementation and reporting back to CLO and CABs on responses to questions raised by community;
o Facilitation of 2-way communication between IAVI and study volunteers, the wider community, CAB, and CRC and escalation of concerns / issues raised by CLOs and CABs to study team and management as appropriate.
o Development of research literacy materials for the specific indication / trial / population in required local languages where required to support effective GPP implementation and research literacy training or address concerns as needed;
o Facilitate effective study results dissemination to study volunteers and communities as needed, working closely with the IAVI study team and CRCs.
• Act as community engagement lead on project teams for assigned studies; contribute community engagement updates to project team meetings and donor reports.
• Provide input on the protocol management plans (PMP) relevant to GPP implementation for the study.
• Facilitate networking of CLOs/CS across CRCs through quarterly calls to further knowledge sharing among peers and build capacity.
• Organize annual CLO/CS Forum to ensure cross-site engagement, sharing of best practices and lessons learned among program participants and to provide training to CLOs/CS as needed.
• Write abstracts, articles, reports, publications and newsletters on GPP and Community Engagement for internal IAVI and external purposes (e.g. conferences) and involve CLOs in co-authoring of abstracts, articles, reports, publications.
• Contribute to the Clinical Development (CD) departmental Standard Operating Procedures for conduct of clinical trials based on IAVI templates and ensures adherence to guidelines for GPP
• Stay up to date on required training’s, including identification of changes in US, EU and other applicable regulations and best practices with regards to clinical trial conduct and GPP.
• Contribute to grant proposals and other fund-raising activities as needed.
• Other duties as assigned.
EDUCATION AND WORK EXPERIENCE:
• Bachelors degree in relevant field required
• Minimum 10 years of experience in clinical trials and experience relevant to community engagement and GPP in support of clinical trials
• Experience in vaccine or infectious disease clinical trials required, strong preference for experience in HIV prevention research
• Experience working on clinical research in LMICs, particularly in Africa
• Expert knowledge of community engagement and Good Participatory Practices
• In-depth knowledge of clinical research and clinical development, including ICH GCP
• Demonstrated ability to successfully lead teams and mentor others
• Outstanding verbal and written communication skills, including PowerPoint and use of other presentation tools
• Certificate of training in GPP, preferred
OTHER KNOWLEDGE, SKILLS, AND ABILITIES:
• Strategic thinking and project management skills
• Ability to translate key scientific and research concepts into layman’s terms
• Ability to present training to audiences of 30 – 50 people
• Able to work independently and take initiative
• Ability to deliver on assigned tasks within assigned deadline
• Excellent verbal and written communication
• Strong organizational skills
• Able to work collaboratively and effectively in large, complex, multi-departmental, cross-functional project teams.
• Able to take responsibility for completion of tasks with high quality according to established program timelines
• Able to develop and manage budgets
• Identify problems and possible solutions and assess the impact on timelines
• Proficient in Microsoft Outlook, Word, Excel, PowerPoint
• Familiarity with HIV, TB, emerging infectious diseases
• Able to adapt to diverse educational and cultural backgrounds, and maintain a high standard of professional conduct as a representative of IAVI
• Travel 15-20%
Work Environment and Physical Demands:
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Mobility to perform the essential functions of the position
• Hearing and speech sufficient to verbally communicate in person and on the telephone constantly (66-100%)
• Typical office environment
• Perform other duties as assigned
please apply on iavi.org