CLINICAL RESEARCH COORDINATOR

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Job Opportunity: Research Coordinator for Cervical Cancer Studies in East Africa and the Center for Global Reproductive Health

We are seeking support for research projects carried out through the Center for Global Reproductive Health (the Center). The ideal candidate is someone who balances a passion for global reproductive health, health equity and implementation research with strong organizational and communication skills, attention to detail and ability to collaborate with colleagues from various backgrounds. This person will coordinate research operations related to international cervical cancer screening and prevention projects in Western Kenya led by Dr. Megan Huchko. This person will work directly with Christina Makarushka, research program leader, to support multiple studies.  All of the research work takes place in East Africa, so this job will involve a significant amount of time coordinating a team through emails and phone calls, which often take place during early mornings and rarely late at night.

Duke Global Health Institute and Center for Global Reproductive Health

The Duke Global Health Institute is a University-Wide Institute to coordinate, support and implement Duke’s interdisciplinary research, education and service activities related to global health. The DGHI is committed to developing and employing new models of education and research that engage international partners and find innovative solutions to global health challenges. The DGHI provides education in global health at the undergraduate, graduate and postgraduate levels, and supports 100 expert faculty working in various disciplines across the University.

The Center for Global Reproductive Health (the Center) was launched in March 2018, with the mission to position Duke as a leader in global reproductive health, fostering expertise on policies, programs, and innovations in reproductive health through rigorous research, education, and strong relationships with partner countries. To do this, the Center convenes faculty, researchers, students, and advocates to address the key policy, cultural and reproductive health issues that impact women’s well-being and empowerment around the world. The Center continues to focus on priority areas that include cervical cancer screening and prevention, family planning and prevention and management of STIs including HIV/AIDS. In the current US and international political climate, the Center is increasing its advocacy work on behalf of reproductive and sexual and gender minority-rights.

Since its launch, the Center has secured funding for collaborative projects with multiple center co-investigators through both NIH and internal Duke grants in the areas of cervical cancer prevention, stigma, health systems strengthening, digital health and global mental health. Faculty at the Center have engaged with learners throughout the University and Medical School and in its partner locations through structured coursework, mentored research projects and clinical rotations. The Center has a field office in Kisumu that maintains partnerships with local non-profits and government organizations to develop the research and programmatic plans around reproductive health and cervical cancer prevention in the region. Local partnerships have increased in recognition of growing Duke expertise in global reproductive health work, with collaborations between multiple reproductive health experts and organizations in the triangle area.

Cervical Cancer Prevention Studies in East Africa

Pocket Colposcope Project

Visual Inspection with Acetic Acid (VIA), the World Health Organization recommended triage test following HPV testing, has widely varied sensitivity and specificity depending on the training level of the provider. We are proposing a single visit model for precision diagnosis and treatment in LMICs for cervical cancer prevention. Two major technological tools are needed to

implement this model: a low-cost method to perform imaging of the cervix and a machine learning algorithm to automate diagnosis in the absence of a provider. We have previously developed the Pocket Colposcope, which has shown high concordance with standard colposcopy at a fraction of the cost and validated it on thousands of women across nearly every continent. We are now in the process of developing a state-of-the-art convolutional neural network (CNN), called Colposcopy Automated Risk Evaluation (CARE), trained with Pocket colposcopy images to automate the diagnostic process. Our current prototype algorithm has been highly successful at classifying cervical pre-cancers from Pocket Colposcope images retrospectively. Our goals for this proposal are fourfold: 1) improve and generalize the performance of Pocket CARE using >10,000 National Cancer Institute (NCI) standard colposcopy images; 2) generate synthetic images to address domain shifts due to environmental and personnel changes between different clinical sites; 3) embed the CARE algorithm into our existing software to enable high quality image capture with the Pocket Colposcope for automated diagnosis 4) validate the performance of Pocket CARE prospectively with a clinical study in Kisumu, Kenya, a site where Pocket CARE would ultimately be adopted. The deliverables for this proposal will be a fully validated Pocket CARE software ready for scale to different clinical scenarios based on location-specific cultural contexts and infrastructure and a comparative effectiveness of Pocket CARE to other publicly available algorithms and standard care.

This project has 5 years of funding, and started May 2022.

mSaada

While HPV-based screening has the potential to be incorporated into simplified protocols, the laboratory testing component requires programs to have capacity to track specimens, results and patient follow-up, which can be a challenge in settings with limited healthcare infrastructure and no electronic medical records. Further, low baseline knowledge of HPV and cervical cancer risk in the community is associated with low rates of screening and follow-up, making effective outreach and education a key component of screening programs. This work is often done by community health volunteers (CHVs) with limited content-specific training. We propose to fill these gaps through an integrated digital platform that includes a mobile app (mSaada) that supports CHVs with patient and specimen tracking and follow-up, and counseling and protocol support. In the R21 phase of this project, we will: (1) work with key stakeholders and local and international developers to finalize the mSaada platform, building on the existing prototype to add patient and specimen tracking functionality; and (2) carry out a pilot study to identify the patient, provider and health system factors necessary to design a trial to evaluate mSaada effectiveness and implementation factors. We will carry out a six-month pilot in two health facilities providing HPV-based screening, and use performance metrics including system usage rates, workflow observations and qualitative data to guide the planning of a cluster-randomized clinical trial (c-RCT) to determine effectiveness of mSaada. In the R33 phase of the project, we will use a hybrid implementation effectiveness design to: (1) conduct an 18-month c-RCT across 12 health facilities to determine the impact of mSaada on cervical cancer screening uptake, treatment acquisition and cervical cancer knowledge levels among women in the community; and (2) measure the requisite implementation factors for mSaada effectiveness, sustainability, and scale-up. The rigorous study design will allow us to determine the clinical impact of mSaada, ensure the local and regional infrastructure has the capacity necessary for sustainability and develop strategies for widespread implementation and scale-up. Collaboration with key stakeholders from the Kenya Ministry of Health will facilitate the development of a long-term sustainability plan as the country moves toward HPV-based cervical cancer screening. We anticipate the mSaada platform will play a pivotal role in facilitating the introduction of HPV-based screening programs that can reach women in settings with limited health care infrastructure.

This project has 5 years of funding, and started August 2022.

Elimisha

In our prior work to evaluate HPV-based screening in Kenya, we found that lack of education about cervical cancer and low awareness of screening benefits, both of which can potentiate cancer-related stigma, were major barriers to screening uptake. Our team also found that misperceptions and stigma about an HPV diagnosis and cancer were associated with reduced rates of follow-up among women who tested positive for HPV.

We propose to incorporate educational components into “Elimisha HPV,” a multilevel stigma- responsive cervical cancer prevention service delivery model for integration within clinics providing HIV- care in western Kenya. Elimisha HPV, which in Kiswahili means to increase understanding of HPV, will include the following components: HPV-testing via self-collection, simplified scripts and video, peer navigators for women with screening or treatment hesitancy, and the option to receive results and information via text messages. To adapt, implement and test the effectiveness of this model, we will: 1) work with key stakeholders to finalize Elimisha HPV 2) compare cervical cancer prevention outcomes and engagement in HIV care in clinics offering the Elimisha HPV model to clinics providing standard of care outreach, education and screening strategies; and 3) identify individual and institutional factors that moderate the effects of Elimisha HPV on cervical cancer prevention outcomes. If effective, this may represent a new model for HPV-based cervical cancer screening as well as a new paradigm for comprehensive, stigma-responsive service delivery packages for people living with HIV.

This project has 3 years of funding, and started July 2022.

Job Responsibilities

Research operations and coordination: 60%

The Research Coordinator will provide general coordination and support for the research projects and Center, including:

• Conduct literature reviews as needed for on-going research or as it relates to upcoming grant submissions
• Participate in research team weekly study calls including note taking, circulating information in a timely manner and managing task lists
• Assist with study budgets and closeouts
• Assist with establishing and maintaining study-level documentation for international studies
• Draft study documents such as protocols, consents, SOPs. study flows, and systems to ensure data security and provenance
• Review data, enrollment logs, and documents as part of monitoring and quality control
• Detect issues related to data capture, collection or management and suggest solutions
• Assist in review of reports prepared by the data team

Ethics and Safety: 25%

• Coordinate and perform study specific regulatory processes across multiple studies such as complete regulatory tasks (Duke and KEMRI) including IRB submissions, maintenance of Oncore and clinicaltrials.gov records.
• Communicate with IRB staff and reviewers and handle issues appropriately
• Oversee study compliance with institutional requirements and policies
• Develop tracking system for regulatory requirements across studies and sites.
• Maintain regulatory binders, Delegation of Authority Logs and adverse events [AE] recording and reporting
• Assist with development or review of Research Data Sharing Plans (RDSPs)

• Coordinate calls, program meetings and retreats
• Facilitate sharing and management of materials through Box or other information storage software
• Purchase supplies, arrange shipment to Kenya, track equipment and devices
• Assist with travel and transportation logistics for research study team, study sites, Center staff, and student travel
• Manage reimbursements as needed (with help of DGHI admin)

Required Qualifications include: Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook; Ability to think critically, solve problems and present solutions effectively; Cultural sensitivity and ability to work with individuals from a variety of different backgrounds and nationalities; Excellent written and verbal communications skills for meeting notes, grant and report writing, technical writing and editing, presentations, and other materials; Ability to multi-task. Excellent attention to detail, follow-through, and accuracy of information; ability to display a commitment to high standards; Undergraduate degree.

Preferred Qualifications include: Prior experience in public health, research administration and/or study coordination (>2 yrs); Training or experience relevant to international health or international health policy; Experience in writing for grants or research publications.

Minimum Qualifications
Education

Completion of an Associate's degree

Experience

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

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