|Location||Cape Town, South Africa|
|Date Posted||Jun 24, 2020|
Engineering / Technical Jobs
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.