Coordination and management quality control for observational and interventional, including both clinic and community-based studies, within the Institute for Population and Precision Health.
This may include multi-institutional and some international studies, many of which are federally funded or funded by pharmaceutical sponsors.
This may include oversight of the collection of clinical data, survey data, environmental data, and associated samples and biospecimens.Â
Coordination; Institutional Review Board (IRB) preparation; development of data collection instruments; assurance of implementation accuracy and study staff compliance; and continuous reporting on milestones, success, and challenges to study leadership.
Assist with subject engagement, screening, recruitment, consent, data and specimen collection, and subject follow-up and retention activities.
Monitor study participants, schedule, and conduct study-related procedures (eg. interviews, phlebotomies, and follow-ups) and establish data quality control checks).
Work with the Scientific Directors and Research Manager in the planning, development, and evaluation of research.
Coordination of data acquisition, entry, QC, and query response.
Assist in the development of new projects and preparation of study reports, and manuscripts for publication.
Assist in the preparation of presentations, media and curricular materials relating to research.
Analyzes, facilitates, and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.
Prepares program conference lists for multidisciplinary conferences and workshops. Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.
Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.
Performs other related work as needed.
Masterâ™s degree in public health, epidemiology or related field.
Supervisory experience with relevant experience (e.g., clinical trials, study coordination, etc.).
Ability to train others
Knowledge in relevant scientific field
Knowledge of research techniques of methods
Knowledge of regulatory policies and procedures
Excellent problem problem-solving skills and analytic skills
Attention to detail and excellent organizational skills
Verbal and written communication skills
Ability to work independently and as part of a team
Knowledge of Microsoft Office
Ability to offer leadership and management of frontline research staff
Some weekend or evening hours may be required for clinical events.
Cover Letter (preferred)
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