The proposed individual will provide regulatory, administrative, and analytical support for an international research group conducting malaria studies in sub-Saharan Africa, primarily based in Uganda and Burkina Faso. The team is based at the Yale School of Public Health in the Department of Epidemiology of Microbial Diseases and focuses its studies on clinical and epidemiological aspects of malaria in vulnerable populations, primarily children. Studies include clinical trials and epidemiologic investigations. The incumbent will serve on a multidisciplinary team with investigators at other U.S.-based institutions and African-based scientists. They will be responsible for several aspects regarding study operations, regulatory oversight, and basic analytical support. The position will require an average of twice yearly travel to sub-Saharan Africa to work with and oversee field sites. It is the incumbent's responsibility to ensure that clinical research commitments are met to the highest standards.
1) Regulatory 15%
Ensure all GCP and HSC certificates are up to date for personnel
Assist with IRB submissions and renewals/modifications
Assist in preparation of progress reports for funding agencies
Assist in development and monitoring of policies and procedures for field sites in accordance with Good Laboratory Clinical Practice (GLCP)
Assist in preparation of informed consent and related documents
Researches and develops safety procedures in accordance with research activities
Work with in-country staff to assist in preparation for regulatory agency audits
Assist in interactions with other collaborating institutions
Community: work with local staff to develop Community Advisory Boards
2) Study operations 60%
Assist in development of investigator-initiated protocols
Create, revise, adapt standard operating procedures, case record forms, and other study related questionnaires
Travel to sub-Saharan African study sites twice per year, on average, to oversee start-up activities, manage study operations, and ensure regulatory compliance. Travel may last 1-2 months per visit.
Assists in developing quality assurance plans for laboratory aspects of studies
Point person for organizing weekly calls and agendas; prepare meeting minutes
Weekly reporting with in-country project PI/study coordinator
Ensures meeting QA study goals and objectives
Ensures proper collection, documentation, and archiving of laboratory specimen source data and samples
Ongoing quality improvement with laboratory staff
Oversees data collection and QA/QC
Works with in-country lab directors to ensure proper collection and storage of specimens
Responsible for systems to inventory, track and ship specimens
Oversee specimen storage, shipments, and relevant permits/MTAs
Implement training procedures for laboratory and other in-country staff
Implement training for in-country staff for new lab assays
Ensure Yale and in-country supply needs are met and maintain relationship with relevant vendors
Assist in creating and overseeing study budgets, justifications, including periodic review of in-country expenditure reports
Assist in projecting program costs through the grant year, and for subsequent years.
Assist with student-related projects
3) Data analysis 25%
Provide regular study recruitment and progress reports
Oversight of primary study databases, including periodic QA/QC
Perform basic statistical tests such as t-tests, chi-square and Fisher's Exact, non-parametric tests, ANOVA, correlation, prevalence
Work with Excel and at least one other advanced statistical program, such as STATA, SAS and R
Preference given to those with expertise in survival analysis, multivariate regression, repeated measures analysis
Assistance in preparation of figures, graphs, and tables for presentation and dissemination of results.
Posting Position Title: Clinical Research Analyst 1
University Job Title: Clinical Research Analyst
Work Week: Standard (M-F equal number of hours per day)
Required Skill/ability 1: Willingness to travel to sub-Saharan Africa twice yearly. Willingness to live in Uganda and/or Burkina Faso.
Required Skill/ability 2: Knowledge of safety and regulatory requirements for clinical research studies. Proficiency in GCP and ICH guidelines.
Required Skill/ability 3: Strong computer skills and technical knowledge of software applications such as Word, Excel, Outlook, and Powerpoint, and Access.
Required Skill/ability 4: Excellent interpersonal and diplomacy skills. Excellent organizational skills, time and management skills. Ability to communicate clearly and succinctly in spoken and written English. Self-motivated individual.
Required Skill/ability 5: Demonstrated ability with research in a laboratory or field site.
Preferred Education, Experience and Skills: Experience in an academic institution working with research teams, particularly Africa and/or infectious diseases-related. Database management experience. Knowledge of French language or willingness to learn French (preferred for Burkina Faso). Knowledge of NIH policies and regulations. Preferred if acquainted with statistical software such as STATA or SAS.
Required Licenses Or Certifications:
Bachelor's degree in a related field and four years of related work experience in the same job family or an equivalent combination of experience and education. Must be knowledgeable in regional and federal regulations with the ability to perform independent decision-making on a daily basis.
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.